APRON: Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT01149369
• Collaborator: (none)
• Enrollment: 126
• Locations: 8
• Arms: 2
• Duration (Months): 29
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Drug: Aprepitant; Drug: Placebo	Phase 2

Detailed Description

APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related disorders. Screening for eligibility and collection of baseline data will span up to 4 weeks after obtaining informed consent and registration. Eligible patients will consist of patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg per day) or placebo for 4 weeks.

The symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary (GCSIDD) for one week at baseline and for four weeks after randomization. In addition, the nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS) for one week at baseline and daily for four weeks after randomization. There will be a 2 week washout period at the end of the treatment to ensure patient safety following the end of treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aprepitant Aprepitant 125 mg per day	Drug: Aprepitant; Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks; Other Names: Emend
Placebo Comparator: Aprepitant-placebo Placebo aprepitant 125mg per day	Drug: Placebo; Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Improvement in Nausea [4 weeks]

   The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of < 25 mm.

Secondary Outcome Measures

1. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) [4 weeks]

   Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

2. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) [4 weeks]

   Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency.

3. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) [4 weeks]

   Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency.

4. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score [4 weeks]

   The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

5. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity [4 weeks]

   Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

6. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity [4 weeks]

   Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

7. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity [4 weeks]

   Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

8. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity [4 weeks]

   Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

9. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity [4 weeks]

   Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

10. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity [4 weeks]

    Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

11. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity [4 weeks]

    Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

12. Clinical Global Patient Impression Score (Patient-rated) [4 weeks]

    The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome.

13. Liver Enzymes and Proteins: Alanine Aminotransferase (ALT) [4 weeks]

    Change from baseline in serum alanine aminotransferase (ALT), U/L

14. Liver Enzymes and Proteins: Aspartate Aminotransferase (AST) [4 weeks]

    Change from baseline in aspartate aminotransferase (AST), U/L

15. Liver Enzymes and Proteins: Total Protein [4 weeks]

    Change from baseline in total protein (g/dL)

16. Hemoglobin A1c (HbA1c) [4 weeks]

    Change from baseline in hemoglobin A1c (HbA1c) (%)

17. Glucose [4 weeks]

    Change from baseline in glucose (mg/dL)

18. Liver Enzymes and Proteins: Albumin [4 weeks]

    Change from baseline in albumin (g/dL)

19. Hemoglobin [4 weeks]

    Change from baseline in hemoglobin (g/dL)

20. Hematocrit [4 weeks]

    Change from baseline in hematocrit

21. White Blood Cell Count (WBC) [4 weeks]

    Change from baseline in white blood cell count (WBC)

22. Red Blood Cell Count (RBC) [4 weeks]

    Change from baseline in red blood cell count (RBC)

23. Platelet Count [4 weeks]

    Change from baseline in platelet count

24. Carbon Dioxide [4 weeks]

    Change from baseline in carbon dioxide (mEg/L)

25. Chloride [4 weeks]

    Change from baseline in chloride (mEq/L)

26. Sodium [4 weeks]

    Change from baseline in sodium (mEq/L)

27. Potassium [4 weeks]

    Change from baseline in potassium (mEq/L)

28. Calcium [4 weeks]

    Change from baseline in calcium (mg/dL)

29. Blood Urea Nitrogen (BUN) [4 weeks]

    Change from baseline in blood urea nitrogen (BUN) (mg/dL)

30. Magnesium [4 weeks]

    Change from baseline in magnesium (mg/dL)

31. Creatinine [4 weeks]

    Change from baseline in creatinine (mg/dL)

32. PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score [4 weeks]

    PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

33. PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore [4 weeks]

    The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

34. PAGI-SYM Severity Index: Fullness/Early Satiety Subscore [4 weeks]

    The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

35. PAGI-SYM Severity Index: Bloating Subscore [4 weeks]

    The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

36. PAGI-SYM Severity Index: Upper Abdominal Pain Subscore [4 weeks]

    The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

37. PAGI-SYM Severity Index: GERD Subscore [4 weeks]

    PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

38. PAGI-SYM Severity Index: Nausea Severity [4 weeks]

    The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

39. PAGI-SYM Severity Index: Vomiting Severity [4 weeks]

    The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

40. PAGI-SYM Severity Index: Retching Severity [4 weeks]

    The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

41. PAGI-SYM Severity Index: Stomach Fullness Severity [4 weeks]

    PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

42. PAGI-SYM Severity Index: Unable to Finish Meal Severity [4 weeks]

    PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

43. PAGI-SYM Severity Index: Excessive Fullness Severity [4 weeks]

    PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

44. PAGI-SYM Severity Index: Loss of Appetite Severity [4 weeks]

    PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

45. PAGI-SYM Severity Index: Bloating Severity [4 weeks]

    The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

46. PAGI-SYM Severity Index: Stomach Distention Severity [4 weeks]

    The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

47. PAGI-SYM Severity Index: Upper Abdominal Pain Severity [4 weeks]

    The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

48. PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity [4 weeks]

    The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

49. PAGI-SYM Severity Index: Lower Abdominal Pain Severity [4 weeks]

    The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

50. PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity [4 weeks]

    The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

51. PAGI-SYM Severity Index: Heartburn During the Day Severity [4 weeks]

    The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

52. PAGI-SYM Severity Index: Heartburn When Lying Down Severity [4 weeks]

    The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

53. PAGI-SYM Severity Index: Chest Discomfort During the Day Severity [4 weeks]

    The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

54. PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity [4 weeks]

    The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

55. PAGI-SYM Severity Index: Regurgitation During the Day Severity [4 weeks]

    The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

56. PAGI-SYM Severity Index: Regurgitation When Lying Down Severity [4 weeks]

    The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

57. PAGI-SYM Severity: Bitter Taste Severity [4 weeks]

    The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

58. PAGI-SYM Severity Index: Constipation Severity [4 weeks]

    The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

59. PAGI-SYM Severity Index: Diarrhea Severity [4 weeks]

    The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

60. Gastrointestinal Symptom Rating Scale (GSRS): Total Score [4 weeks]

    The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

61. Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score [4 weeks]

    The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

62. Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score [4 week]

    The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

63. Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score [4 weeks]

    The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

64. Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score [4 weeks]

    The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

65. Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score [4 weeks]

    The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

66. Brief Pain Inventory: Severity Score [4 weeks]

    The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

67. Brief Pain Inventory: Interference Score [4 weeks]

    The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

68. Beck Depression Inventory (BDI) Score [4 weeks]

    The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

69. State-Trait Anxiety Inventory (STAI): State Anxiety Score [4 weeks]

    The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

70. State-Trait Anxiety Inventory (STAI): Trait Anxiety Score [4 weeks]

    The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

71. Satiety Test, Volume Consumed [4 weeks]

    The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement).

72. Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state).

73. Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state).

74. Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).

75. Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).

76. Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).

77. Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).

78. Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).

79. Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement [4 weeks]

    Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years or older at registration

• Gastric emptying scintigraphy within 2 years of registration

• Normal upper endoscopy or upper GI series within 2 years of registration

• Symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of greater than or equal to 21

• Significant nausea defined with a visual analog scale (VAS) score of greater than or equal to 25 mm on a 0 to 100 mm scale

Exclusion Criteria:

• Another active disorder which could explain symptoms in the opinion of the investigator

• Use of narcotics more than 3 days per week

• Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of normal (ULN) or a Child-Pugh score of 10 or greater

• Contraindications to aprepitant such as hypersensitivity or allergy

• Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride

• Pregnancy or nursing

• Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study

• Failure to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Pacific Medical Center	San Francisco	California	United States	94115
2	Stanford University	Stanford	California	United States	94305-5187
3	University of Louisville	Louisville	Kentucky	United States	40202
4	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
5	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
6	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
7	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
8	Texas Tech University Health Sciences Center	El Paso	Texas	United States	79905

Sponsors and Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Study Director: Frank Hamilton, MD, MPH, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Gastroparesis Clinical Research Consortium website

Publications

None provided.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT01149369
• Other Study ID Numbers: IND - DK-GpCRC-4APRON; U01DK073983; U01DK073975; U01DK073985; U01DK074007; U01DK073974; U01DK074008; U01DK074035
• First Posted: Jun 23, 2010
• Last Update Posted: May 8, 2019
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): gastroparesis; nausea; vomiting
• Additional relevant MeSH terms: Gastroparesis; Nausea; Vomiting; Aprepitant

Study Results

Participant Flow

Recruitment Details	Between April 2013 and July 2015, 126 patients were enrolled at eight participating medical centers, of whom 63 were randomized to aprepitant and 63 to placebo
Pre-assignment Detail	Adults, 18 years or older, with symptoms compatible with gastroparesis for 6 months, who had a 4-hour gastric emptying scintigraphy test and a total score >21 on the Gastroparesis Cardinal Symptom Index (GCSI) and a visual analog scale (VAS) mean score of nausea after 7 days of >25 mm on a 0 to 100 mm scale were considered for enrollment.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Period Title: Overall Study
STARTED	63	63
COMPLETED	57	60
NOT COMPLETED	6	3

Baseline Characteristics

Arm/Group Title	Aprepitant	Aprepitant-placebo	Total
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Total of all reporting groups
Overall Participants	63	63	126
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.9 (14.8)	46.8 (13.5)	44.8 (14.3)
Sex: Female, Male (Count of Participants)
Female	49 77.8%	52 82.5%	101 80.2%
Male	14 22.2%	11 17.5%	25 19.8%
Race/Ethnicity, Customized (participants) [Number]
White	53 84.1%	59 93.7%	112 88.9%
Black	8 12.7%	2 3.2%	10 7.9%
Other	2 3.2%	2 3.2%	4 3.2%
Region of Enrollment (participants) [Number]
United States	63 100%	63 100%	126 100%
Diabetes type 1 or type 2, No. (participants) [Number]
Have diabetes type 1 or type 2	24 38.1%	13 20.6%	37 29.4%
Do not have diabetes type 1 or type 2	39 61.9%	50 79.4%	89 70.6%
Body mass index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.8 (8.3)	28.0 (7.5)	27.9 (7.9)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	75.4 (22.8)	75.1 (20.6)	75.2 (21.7)
Waist circumference (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	90.9 (17.2)	91.3 (18.0)	91.1 (17.5)
Waist to hip ratio (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	0.9 (0.1)	0.9 (0.1)	0.9 (0.1)
Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	121.1 (17.8)	122.1 (15.0)	121.6 (16.4)
Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	73.6 (11.6)	75.0 (11.3)	74.3 (11.4)
Medications in past month: proton pump inhibitors (participants) [Number]
Took medication	42 66.7%	51 81%	93 73.8%
Did not take medication	21 33.3%	12 19%	33 26.2%
Medications in past month: benzodiazepine or anxiolytic (participants) [Number]
Took medication	13 20.6%	27 42.9%	40 31.7%
Did not take medication	50 79.4%	36 57.1%	86 68.3%
Medications in past month: prokinetic (participants) [Number]
Took medication	25 39.7%	18 28.6%	43 34.1%
Did not take medication	38 60.3%	45 71.4%	83 65.9%
Medications in past month: antiemetic (participants) [Number]
Took medication	44 69.8%	49 77.8%	93 73.8%
Did not take medication	19 30.2%	14 22.2%	33 26.2%
Medications in past month: selective serotonin reuptake inhibitors (SSRI) (participants) [Number]
Took medication	9 14.3%	18 28.6%	27 21.4%
Did not take medication	54 85.7%	45 71.4%	99 78.6%
Medications in past month: tricyclic antidepressant (TCA) (participants) [Number]
Took medication	11 17.5%	16 25.4%	27 21.4%
Did not take medication	52 82.5%	47 74.6%	99 78.6%
Medications in past month: other antidepressant (participants) [Number]
Took medication	12 19%	10 15.9%	22 17.5%
Did not take medication	51 81%	53 84.1%	104 82.5%
Medications in past month: narcotic (participants) [Number]
Took medication	6 9.5%	4 6.3%	10 7.9%
Did not take medication	57 90.5%	59 93.7%	116 92.1%
Medications in past month: neuropathic or pain modulator... (participants) [Number]
Took medication	27 42.9%	29 46%	56 44.4%
Did not take medication	36 57.1%	34 54%	70 55.6%
7-day nausea visual analog scale (VAS) score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	63.0 (21.5)	64.1 (20.2)	63.6 (20.8)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (hours of nausea) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours of nausea]	9.0 (7.0)	9.3 (7.1)	9.2 (7.1)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.2 (0.9)	2.3 (0.7)	2.3 (0.8)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.6 (0.8)	2.6 (0.8)	2.6 (0.8)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.0 (1.0)	0.9 (1.0)	1.0 (1.0)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early satiety severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.6 (1.1)	2.7 (0.9)	2.6 (1.0)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive fullness severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.7 (1.1)	2.8 (0.9)	2.7 (1.0)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.2 (1.4)	2.6 (1.1)	2.4 (1.2)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper abdominal pain severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.3 (1.2)	2.3 (1.0)	2.3 (1.1)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. episodes) (number of episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of episodes]	1.3 (1.6)	1.1 (1.5)	1.2 (1.5)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. episodes) (number of episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of episodes]	2.0 (2.5)	2.3 (2.8)	2.1 (2.6)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall symptom severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.5 (0.8)	2.6 (0.7)	2.6 (0.8)
PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI), total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.4 (0.9)	3.3 (0.7)	3.4 (0.8)
PAGI-SYM Severity index: Nausea/vomiting severity subscore (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.3 (1.1)	2.8 (0.9)	3.0 (1.1)
PAGI-SYM Severity index: Nausea severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.2 (0.8)	4.0 (0.9)	4.1 (0.9)
PAGI-SYM Severity index: Retching severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.0 (1.6)	2.6 (1.3)	2.8 (1.5)
PAGI-SYM Severity index: Vomiting severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.6 (1.8)	1.9 (1.6)	2.2 (1.7)
PAGI-SYM Severity index: Fullness/early satiety subscore (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.7 (1.0)	3.7 (0.8)	3.7 (0.9)
PAGI-SYM Severity index: Bloating subscore (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.3 (1.4)	3.4 (1.4)	3.4 (1.4)
PAGI-SYM Severity index: Upper abdominal pain subscore (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.4 (1.3)	3.3 (1.3)	3.4 (1.3)
PAGI-SYM Severity index: Lower abdominal pain (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.4 (1.6)	2.5 (1.4)	2.5 (1.5)
PAGI-SYM Severity index: Lower abdominal discomfort (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.5 (1.6)	2.6 (1.4)	2.6 (1.5)
PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) subscore (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.4 (1.4)	2.3 (1.4)	2.3 (1.4)
PAGI-SYM Severity index: Constipation severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.9 (1.7)	2.6 (1.8)	2.8 (1.8)
PAGI-SYM Severity index: Diarrhea severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.6 (1.7)	1.8 (1.7)	1.7 (1.7)
PAGI-SYM Severity index: Nausea/vomiting predominant symptom, No. (participants) [Number]
Nausea/vomiting predominant symptom	38 60.3%	39 61.9%	77 61.1%
Nausea/vomiting not predominant symptom	25 39.7%	24 38.1%	49 38.9%
Clinical Global Patient Impression Score (patient-rated) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	-0.6 (1.1)	-0.7 (1.1)	-0.6 (1.1)
Brief Pain Inventory: severity score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.7 (2.5)	4.6 (2.5)	4.6 (2.5)
Brief Pain Inventory: Interference score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.4 (3.1)	5.4 (3.0)	4.9 (3.1)
Beck Depression Inventory (BDI): Total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.0 (11.8)	18.3 (12.6)	18.2 (12.1)
Beck Depression Inventory (BDI): Severe depression, No. (participants) [Number]
Have severe depression	11 17.5%	10 15.9%	21 16.7%
Do not have severe depression	52 82.5%	53 84.1%	105 83.3%
State-Trait Anxiety Inventory (STAI): State anxiety score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	39.6 (13.9)	41.9 (13.9)	40.7 (13.9)
State-Trait Anxiety Inventory (STAI): Severe state anxiety, No. (participants) [Number]
Have severe state anxiety	15 23.8%	19 30.2%	34 27%
Do not have severe state anxiety	48 76.2%	44 69.8%	92 73%
State-Trait Anxiety Inventory (STAI): Trait anxiety score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	40.3 (14.2)	43.0 (13.2)	41.6 (13.7)
State-Trait Anxiety Inventory: Severe trait anxiety, No. (participants) [Number]
Have severe trait anxiety	17 27%	19 30.2%	36 28.6%
Do not have severe trait anxiety	46 73%	44 69.8%	90 71.4%
SF-36 Quality of Life (QOL): Physical component summary score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	33.5 (9.5)	29.8 (8.8)	31.6 (9.4)
SF-36 Quality of Life (QOL): Mental component summary score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	41.4 (14.3)	40.5 (13.5)	40.9 (13.9)
Scintigraphic gastric emptying (GES): Percent gastric retention at 1 hour (percent retention) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent retention]	69.7 (20.0)	73.0 (19.3)	71.3 (19.6)
Scintigraphic gastric emptying (GES): Percent gastric retention at 2 hours (percent retention) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent retention]	45.6 (24.9)	53.1 (23.4)	49.4 (24.4)
Scintigraphic gastric emptying (GES): Percent gastric retention at 4 hours (percent retention) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent retention]	17.8 (21.8)	20.4 (17.5)	19.1 (19.7)
Scintigraphic gastric emptying (GES): Delayed gastric emptying, No. (participants) [Number]
Have delayed gastric emptying	29 46%	43 68.3%	72 57.1%
Do not have delayed gastric emptying	34 54%	20 31.7%	54 42.9%
Scintigraphic gastric emptying (GES): Rapid gastric emptying, No. (participants) [Number]
Have rapid gastric emptying	4 6.3%	2 3.2%	6 4.8%
Do not have rapid gastric emptying	59 93.7%	61 96.8%	120 95.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Improvement in Nausea
Description	The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of < 25 mm.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	63	63
Number [participants]	29 46%	25 39.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments	Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was < 25 mm.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by clinic
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.8 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours)
Description	Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [hours of nausea]	-2.5 (3.2)	-1.2 (4.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -2.8 to -0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes)
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [number of episodes]	-0.5 (1.0)	-0.4 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.3 to 0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes)
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [number of episodes]	-0.5 (1.5)	-0.7 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score
Description	The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-0.5 (0.9)	-0.4 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-0.8 (1.0)	-0.5 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-0.4 (0.8)	-0.2 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.3 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-0.7 (0.9)	-0.3 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.7 to -0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.6 (0.9)	-0.4 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	0.1 (0.2)	0.08 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.1 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.6 (1.0)	-0.4 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.5 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity
Description	Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-0.7 (0.8)	-0.4 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.6 to -0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Clinical Global Patient Impression Score (Patient-rated)
Description	The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	1.3 (1.4)	1.0 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -0.1 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Liver Enzymes and Proteins: Alanine Aminotransferase (ALT)
Description	Change from baseline in serum alanine aminotransferase (ALT), U/L
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [U/L]	2.3 (36.6)	0.8 (7.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.59
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; -7.0 to 12.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Liver Enzymes and Proteins: Aspartate Aminotransferase (AST)
Description	Change from baseline in aspartate aminotransferase (AST), U/L
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [U/L]	3.1 (30.2)	0.9 (7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; -5.9 to 10.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Liver Enzymes and Proteins: Total Protein
Description	Change from baseline in total protein (g/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [g/dL]	0.0 (0.4)	-0.1 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.1 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Hemoglobin A1c (HbA1c)
Description	Change from baseline in hemoglobin A1c (HbA1c) (%)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [percent glycosylated hemoglobin]	-0.1 (1.0)	0.1 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.97
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -0.5 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Glucose
Description	Change from baseline in glucose (mg/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mg/dL]	9.6 (66.8)	7.0 (44.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; -18.0 to 24.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Liver Enzymes and Proteins: Albumin
Description	Change from baseline in albumin (g/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [g/dL]	-0.1 (0.4)	-0.1 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.46
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Hemoglobin
Description	Change from baseline in hemoglobin (g/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [g/dL]	-0.1 (0.9)	-0.2 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Hematocrit
Description	Change from baseline in hematocrit
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [percentage RBCs]	-0.4 (2.7)	-0.4 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.7 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	White Blood Cell Count (WBC)
Description	Change from baseline in white blood cell count (WBC)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [x10^9 cells/L]	-0.3 (1.5)	-0.3 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Red Blood Cell Count (RBC)
Description	Change from baseline in red blood cell count (RBC)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [x10^6 cells/microliter]	-0.1 (0.3)	-0.1 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -0.1 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Secondary Outcome

Title	Platelet Count
Description	Change from baseline in platelet count
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [x10^3 cells/microliter]	-7.3 (47.1)	4.8 (38.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.9
	Confidence Interval	(2-Sided) 95%; -26.5 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	Carbon Dioxide
Description	Change from baseline in carbon dioxide (mEg/L)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mEq/L]	-0.4 (2.5)	0.4 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -1.5 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

26. Secondary Outcome

Title	Chloride
Description	Change from baseline in chloride (mEq/L)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mEq/L]	0.6 (3.0)	-0.2 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -0.7 to 1.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Secondary Outcome

Title	Sodium
Description	Change from baseline in sodium (mEq/L)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mEq/L]	-0.3 (2.3)	-0.7 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -0.9 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

28. Secondary Outcome

Title	Potassium
Description	Change from baseline in potassium (mEq/L)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mEq/L]	0.1 (0.5)	0.0 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

29. Secondary Outcome

Title	Calcium
Description	Change from baseline in calcium (mg/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mg/dL]	-0.1 (0.4)	-0.1 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.76
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -0.1 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

30. Secondary Outcome

Title	Blood Urea Nitrogen (BUN)
Description	Change from baseline in blood urea nitrogen (BUN) (mg/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mg/dL]	-0.9 (4.6)	-0.3 (3.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -2.0 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

31. Secondary Outcome

Title	Magnesium
Description	Change from baseline in magnesium (mg/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mg/dL]	0.0 (0.2)	-0.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; 0.0 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

32. Secondary Outcome

Title	Creatinine
Description	Change from baseline in creatinine (mg/dL)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [mg/dL]	-0.1 (0.2)	0.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to -0
	Parameter Dispersion	Type: Value:
	Estimation Comments

33. Secondary Outcome

Title	PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score
Description	PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.3 (1.0)	-0.7 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

34. Secondary Outcome

Title	PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore
Description	The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.7 (1.3)	-0.7 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -1.2 to -0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

35. Secondary Outcome

Title	PAGI-SYM Severity Index: Fullness/Early Satiety Subscore
Description	The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.0 (1.3)	-0.7 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.7 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Secondary Outcome

Title	PAGI-SYM Severity Index: Bloating Subscore
Description	The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.2 (1.2)	-0.6 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -1.2 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

37. Secondary Outcome

Title	PAGI-SYM Severity Index: Upper Abdominal Pain Subscore
Description	The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.1 (1.5)	-0.6 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

38. Secondary Outcome

Title	PAGI-SYM Severity Index: GERD Subscore
Description	PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.1 (1.3)	-0.6 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.8 to -0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

39. Secondary Outcome

Title	PAGI-SYM Severity Index: Nausea Severity
Description	The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.8 (1.5)	-1.0 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -1.3 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

40. Secondary Outcome

Title	PAGI-SYM Severity Index: Vomiting Severity
Description	The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.6 (1.7)	-0.5 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -1.1 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

41. Secondary Outcome

Title	PAGI-SYM Severity Index: Retching Severity
Description	The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	59	63
Mean (Standard Deviation) [units on a scale]	-1.7 (1.6)	-0.8 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -2.3 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

42. Secondary Outcome

Title	PAGI-SYM Severity Index: Stomach Fullness Severity
Description	PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.1 (1.6)	-0.5 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

43. Secondary Outcome

Title	PAGI-SYM Severity Index: Unable to Finish Meal Severity
Description	PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.8 (1.4)	-0.6 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.8 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

44. Secondary Outcome

Title	PAGI-SYM Severity Index: Excessive Fullness Severity
Description	PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.1 (1.4)	-0.6 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

45. Secondary Outcome

Title	PAGI-SYM Severity Index: Loss of Appetite Severity
Description	PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.9 (1.6)	-0.9 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.72
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

46. Secondary Outcome

Title	PAGI-SYM Severity Index: Bloating Severity
Description	The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.2 (1.4)	-0.5 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -1.2 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

47. Secondary Outcome

Title	PAGI-SYM Severity Index: Stomach Distention Severity
Description	The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.1 (1.3)	-0.7 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

48. Secondary Outcome

Title	PAGI-SYM Severity Index: Upper Abdominal Pain Severity
Description	The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.0 (1.6)	-0.5 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

49. Secondary Outcome

Title	PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity
Description	The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.2 (1.6)	-0.7 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -1.0 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

50. Secondary Outcome

Title	PAGI-SYM Severity Index: Lower Abdominal Pain Severity
Description	The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.8 (1.4)	-0.6 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.8 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

51. Secondary Outcome

Title	PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity
Description	The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.1 (1.4)	-0.6 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

52. Secondary Outcome

Title	PAGI-SYM Severity Index: Heartburn During the Day Severity
Description	The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.2 (1.5)	-0.6 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

53. Secondary Outcome

Title	PAGI-SYM Severity Index: Heartburn When Lying Down Severity
Description	The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.2 (1.5)	-0.7 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

54. Secondary Outcome

Title	PAGI-SYM Severity Index: Chest Discomfort During the Day Severity
Description	The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.1 (1.5)	-0.7 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.8 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

55. Secondary Outcome

Title	PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity
Description	The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.9 (1.5)	-0.6 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -7 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

56. Secondary Outcome

Title	PAGI-SYM Severity Index: Regurgitation During the Day Severity
Description	The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.2 (1.7)	-0.5 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -1.1 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

57. Secondary Outcome

Title	PAGI-SYM Severity Index: Regurgitation When Lying Down Severity
Description	The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.3 (1.7)	-0.5 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -1.2 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

58. Secondary Outcome

Title	PAGI-SYM Severity: Bitter Taste Severity
Description	The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.8 (1.6)	-0.5 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.8 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

59. Secondary Outcome

Title	PAGI-SYM Severity Index: Constipation Severity
Description	The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.8 (1.6)	-0.3 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

60. Secondary Outcome

Title	PAGI-SYM Severity Index: Diarrhea Severity
Description	The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.1 (1.4)	-0.2 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.98
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.5 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

61. Secondary Outcome

Title	Gastrointestinal Symptom Rating Scale (GSRS): Total Score
Description	The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.8 (0.9)	-0.5 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.7 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

62. Secondary Outcome

Title	Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score
Description	The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.1 (1.5)	-0.7 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

63. Secondary Outcome

Title	Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score
Description	The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 week

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.3 (1.1)	-0.7 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

64. Secondary Outcome

Title	Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score
Description	The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The small number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.7 (1.3)	-0.7 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

65. Secondary Outcome

Title	Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score
Description	The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.5 (1.6)	0.1 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -1.0 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

66. Secondary Outcome

Title	Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score
Description	The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-0.8 (1.3)	-0.4 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

67. Secondary Outcome

Title	Brief Pain Inventory: Severity Score
Description	The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.0 (2.6)	-0.7 (2.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -1.1 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

68. Secondary Outcome

Title	Brief Pain Inventory: Interference Score
Description	The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.1 (2.6)	-1.0 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -1.3 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

69. Secondary Outcome

Title	Beck Depression Inventory (BDI) Score
Description	The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-4.6 (8.5)	-2.4 (5.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 95%; -4.7 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

70. Secondary Outcome

Title	State-Trait Anxiety Inventory (STAI): State Anxiety Score
Description	The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-3.1 (8.7)	-1.7 (10.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95%; -5.2 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

71. Secondary Outcome

Title	State-Trait Anxiety Inventory (STAI): Trait Anxiety Score
Description	The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	56	61
Mean (Standard Deviation) [units on a scale]	-1.8 (8.8)	-0.7 (8.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.30
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -4.6 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

72. Secondary Outcome

Title	Satiety Test, Volume Consumed
Description	The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Median (Inter-Quartile Range) [mL]	-13.0	9.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-21.2
	Confidence Interval	(2-Sided) 95%; -70.5 to 28.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

73. Secondary Outcome

Title	Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	-4.6 (24.6)	2.8 (21.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95%; -12.0 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

74. Secondary Outcome

Title	Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	2.1 (17.7)	0.5 (19.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; -4.1 to 8.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

75. Secondary Outcome

Title	Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	1.0 (19.9)	-1.0 (16.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.68
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -4.5 to 6.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

76. Secondary Outcome

Title	Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	1.0 (15.8)	0.8 (15.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -3.6 to 7.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

77. Secondary Outcome

Title	Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	1.5 (12.3)	-1.6 (12.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -2.2 to 5.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

78. Secondary Outcome

Title	Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	-2.1 (9.7)	-0.8 (14.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.8
	Confidence Interval	(2-Sided) 95%; -8.5 to -1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

79. Secondary Outcome

Title	Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week followup visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	2.1 (13.5)	-0.2 (13.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.57
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -3.4 to 6.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

80. Secondary Outcome

Title	Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Description	Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Arm/Group Title	Aprepitant	Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Measure Participants	48	55
Mean (Standard Deviation) [average power in frequency region, %]	-0.8 (7.3)	-0.5 (5.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant, Aprepitant-placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.84
	Confidence Interval	(2-Sided) 95%; -2.6 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Aprepitant		Aprepitant-placebo
Arm/Group Description	Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks		Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
All Cause Mortality
	Aprepitant		Aprepitant-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/63 (0%)
Serious Adverse Events
	Aprepitant		Aprepitant-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/63 (1.6%)		0/63 (0%)
Endocrine disorders
Hypoglycemia	1/63 (1.6%)	1	0/63 (0%)	0
Other (Not Including Serious) Adverse Events
	Aprepitant		Aprepitant-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/63 (33.3%)		11/63 (17.5%)
Blood and lymphatic system disorders
Nosebleed	1/63 (1.6%)	1	0/63 (0%)	0
Bruising	0/63 (0%)	0	1/63 (1.6%)	1
Eye disorders
Flashing lights/floaters	0/63 (0%)	0	1/63 (1.6%)	1
Gastrointestinal disorders
Nausea, vomiting	1/63 (1.6%)	1	1/63 (1.6%)	1
Nausea	1/63 (1.6%)	1	2/63 (3.2%)	2
Vomiting	0/63 (0%)	0	1/63 (1.6%)	1
Gastrointestinal - Other (abdominal pain)	3/63 (4.8%)	3	2/63 (3.2%)	2
Diarrhea	0/63 (0%)	0	1/63 (1.6%)	1
Nausea, abdominal pain, diarrhea	1/63 (1.6%)	1	0/63 (0%)	0
Diarrhea, loss of appetite	1/63 (1.6%)	1	0/63 (0%)	0
Gastrointestinal - Other (fainting sensation)	1/63 (1.6%)	1	0/63 (0%)	0
Constipation	1/63 (1.6%)	1	0/63 (0%)	0
Gastrointestinal - Other (Nausea, malaise)	1/63 (1.6%)	1	0/63 (0%)	0
General disorders
Fatigue	2/63 (3.2%)	2	2/63 (3.2%)	2
Diarrhea, syncope	1/63 (1.6%)	1	0/63 (0%)	0
Immune system disorders
Rhinitis	1/63 (1.6%)	1	0/63 (0%)	0
Metabolism and nutrition disorders
Hypokalemia	1/63 (1.6%)	1	0/63 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other (neck and right hand pain)	1/63 (1.6%)	1	0/63 (0%)	0
Arthralgia	0/63 (0%)	0	1/63 (1.6%)	1
Musculoskeletal - Other (Limb pain)	1/63 (1.6%)	1	0/63 (0%)	0
Nervous system disorders
Dizziness	2/63 (3.2%)	2	0/63 (0%)	0
Headache	2/63 (3.2%)	2	0/63 (0%)	0
Neurology - other	0/63 (0%)	0	1/63 (1.6%)	1
Psychiatric disorders
Depression	0/63 (0%)	0	1/63 (1.6%)	1
Renal and urinary disorders
Renal/Genitourinary - Other (Bleeding)	1/63 (1.6%)	1	0/63 (0%)	0
Fibromyalgia cystitis	1/63 (1.6%)	1	0/63 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis	0/63 (0%)	0	1/63 (1.6%)	1
Skin and subcutaneous tissue disorders
Bruising	1/63 (1.6%)	1	0/63 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.