Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01642615
• Collaborator: (none)
• Enrollment: 63
• Locations: 61
• Arms: 3
• Duration (Months): 28
• Patients Per Site: 1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease; Erosive Esophagitis	Drug: Dexlansoprazole; Drug: Dexlansoprazole; Drug: Placebo	Phase 2

Detailed Description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat adolescents who have erosive esophagitis and heartburn and maintenance of healing of EE.

The study planned to enroll approximately 60 patients.

The study consisted of 3 periods:

1. Screening ((21 [+5] days)

2. Treatment (8 weeks for healing, 16 weeks for maintenance),

3. Post-Treatment Follow-up (up to 3 months).

During screening, participants used an electronic diary (eDiary) daily to document the presence of daytime and nighttime heartburn symptoms and the degree to which heartburn hurt (hereinafter referred to as severity), and to record their use of rescue medication (antacid).

During the first 8 week treatment period, all participants received dexlansoprazole 60 mg, once daily (QD). At the Week 8 visit, participants underwent endoscopy to assess healing of EE. Participants whose EE had not healed were discontinued from the study.

Participants whose EE had healed were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• dexlansoprazole 30 mg QD

• Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

All participants were asked to take one tablet each morning without regard to food throughout the study. Throughout both phases of the Treatment Period, all participants continued to use the eDiary to document the presence or absence and severity of daytime and nighttime heartburn symptoms and the use of rescue medication.

This multi-center trial was conducted worldwide. The overall time to participate in this study was 39 weeks. Participants made multiple visits to the clinic, and were contacted by telephone during the study

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healing Phase: Dexlansoprazole 60 mg Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Drug: Dexlansoprazole; Dexlansoprazole capsules; Other Names: Dexilant
Experimental: Maintenance Phase: Dexlansoprazole 30 mg Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.	Drug: Dexlansoprazole; Dexlansoprazole capsules; Other Names: Dexilant
Experimental: Maintenance Phase: Placebo Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.	Drug: Placebo; Dexlansoprazole placebo-matching capsules

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period [8 weeks]

   An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.

2. Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period [From Week 8 to Week 24]

   An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.

Secondary Outcome Measures

1. Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8 [8 weeks]

   Healing of EE was assessed by endoscopy.

2. Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24 [From Week 8 to Week 24]

   Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.

3. Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment [8 weeks]

   Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.

4. Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24 [Weeks 8 to 24]

   The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. In the opinion of the investigator, the participant and parent(s) or legal guardian are capable of understanding and complying with protocol requirements.

2. Prior to any study-specific procedures being performed, the informed consent and the assent form, according to local country requirements, must be signed and dated by parent(s) or legal guardian and by the participant respectively.

3. The participant has a medical history of symptoms of Gastroesophageal Reflux Disease (GERD) for at least 3 months prior to Screening (signed informed consent form and assent, if applicable) as assessed by the investigator.

4. The participant has met the electronic diary qualification criteria as assessed by the electronic daily diary defined as follows: heartburn (burning or hurting in your throat, chest, or stomach) on at least 3 of 7 days.(Note: if an endoscopy done within 1 week of signing informed consent and assent is used to confirm diagnosis of EE, the subject does not need to meet this criterion).

5. The participant has endoscopic evidence of EE (LA Grade A-D) based on the screening endoscopy.

6. The participant is male or female and aged 12 to 17 years, inclusive.

7. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent and assent throughout the duration of the study and for 30 days after last dose of study medication.

8. A female participant of childbearing potential who is or may become sexually active agrees to routinely use adequate contraception from the time of signing the informed consent and assent until 30 days after the last dose of study medication.

Exclusion Criteria:

1. Participant has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests clinically significant, uncontrolled underlying disease or condition (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.

2. The participant has a co-existing disease affecting the esophagus (eg, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.

3. The participant has known history of Barrett's with dysplastic changes in the esophagus.

4. The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic findings suggestive of EoE.

5. The participant has a history of celiac disease or participant tests positive for tissue transglutaminase (tTG) antibody.

6. The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.

7. Participant has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.

8. Participant has taken any proton pump inhibitor (PPI) within 1 week (7 days) prior to the Screening Visit.

9. Participant tests positive for H. pylori.

10. The participant has a history of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) or antacid containing Mg(OH)2 and/or Al(OH)3 or simethicone.

11. The participant is required to take excluded medications or it is anticipated that the participant will require treatment with at least one of the disallowed concomitant medications during the study evaluation period as specified in the Excluded Medications and Treatments Section 7.3.

12. The participant has a history of malignant disease (except basal cell carcinoma) within 5 years prior to Screening.

13. The participant has a condition that may require inpatient surgery during the course of the study.

14. The participant requires dilatation of esophageal strictures and/or strictures preventing passage of the endoscope during the Screening endoscopy. Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) is acceptable.

15. The participant is known to be human immunodeficiency virus (HIV) positive.

16. The participant has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition.

17. The participant has a history of gastric, duodenal or esophageal surgery except simple oversew of an ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG) placement is allowed.

18. The participant had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

19. The participant has donated or lost ≥300 mL blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.

20. The participant has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug.

21. The participant has any Screening Visit 1 abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the participant from entering the study; or the participant has: creatinine >1.5 mg/dL, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevated above the limits of normal values.

22. If female, the participant is pregnant or lactating or intending to become pregnant before, during or within 30 days after last dose of study medication; or intending to donate ova during such time period.

23. If male, the participant intends to donate sperm during the course of this study or within 30 days after last dose of study drug.

24. The participant, participant's Parent(s) or Legal Guardian is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study or may consent and assent under duress. Students of the institution/research facility who are under the supervision of, or in a subordinate role to, the investigator are also ineligible.

25. The participant or participant's Parent(s) or Legal Guardian, in the opinion of the investigator, is unlikely to comply with the protocol requirements or is unsuitable for any other reason.

26. The participant has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Huntsville	Alabama	United States
2		Mobile	Alabama	United States
3		Phoenix	Arizona	United States
4		Tucson	Arizona	United States
5		Anaheim	California	United States
6		Los Angeles	California	United States
7		San Francsco	California	United States
8		Centennial	Colorado	United States
9		Thornton	Colorado	United States
10		Chicago	Illinois	United States
11		Park Ridge	Illinois	United States
12		Indianapolis	Indiana	United States
13		Louisville	Kentucky	United States
14		Boston	Massachusetts	United States
15		Flint	Michigan	United States
16		Plymouth	Minnesota	United States
17		Jackson	Mississippi	United States
18		Kansas City	Missouri	United States
19		Mays Landing	New Jersey	United States
20		Brooklyn	New York	United States
21		Toledo	Ohio	United States
22		Youngstown	Ohio	United States
23		Greenville	South Carolina	United States
24		Kingsport	Tennessee	United States
25		Ft. Worth	Texas	United States
26		Houston	Texas	United States
27		Laredo	Texas	United States
28		San Antonio	Texas	United States
29		Ogden	Utah	United States
30		Salt Lake City	Utah	United States
31		Fairfax	Virginia	United States
32		Norfolk	Virginia	United States
33		Bruxelles		Belgium
34		Passo Fundo	Rio Grande do Sul	Brazil
35		Porto Alegre	Rio Grande do Sul	Brazil
36		Santo Andre	Sao Paulo	Brazil
37		Santo André	Sao Paulo	Brazil
38		São José do Rio Preto	Sao Paulo	Brazil
39		Debrecen		Hungary
40		Györ		Hungary
41		Miskolc		Hungary
42		Nyiregyhaza		Hungary
43		Pecs		Hungary
44		Bari		Italy
45		Messina		Italy
46		Roma		Italy
47		Mexico	Distrito Federal	Mexico
48		Monterrey	Nuevo León	Mexico
49		Culiacan	Sinaloa	Mexico
50		Bydgoszcz		Poland
51		Krakow		Poland
52		Rzeszow		Poland
53		Szczecin		Poland
54		Torun		Poland
55		Warszawa		Poland
56		Wroclaw		Poland
57		Amadora		Portugal
58		Braga		Portugal
59		Coimbra		Portugal
60		Lisboa		Portugal
61		Porto		Portugal

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director, Clinical Science, Takeda Global Research and Development Center, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Dexilant Package Insert

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT01642615
• Other Study ID Numbers: TAK-390MR_207; U1111-1128-6117; 2012-001681-15
• First Posted: Jul 17, 2012
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Keywords provided by Takeda: Drug therapy
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis; Heartburn; Dexlansoprazole; Lansoprazole

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 18 investigative sites in Mexico, Poland, Portugal and the United States from 22 June 2012 (first participant to sign the informed consent) to 10 November 2014.
Pre-assignment Detail	Sixty three adolescents with a diagnosis of erosive esophagitis (EE) were enrolled in the dexlansoprazole delayed release 60 mg capsules open label phase. One participant was not treated. Participants with healed EE were randomized into one of 2 treatment groups: dexlansoprazole delayed release 30 mg capsules or placebo in the maintenance phase.

Arm/Group Title	Healing Phase: Dexlansoprazole 60 mg	Maintenance Phase: Dexlansoprazole 30 mg	Maintenance Phase: Placebo
Arm/Group Description	Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.	Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Period Title: Open Label Maintenance Phase
STARTED	63	0	0
Safety Analysis Set	62	0	0
COMPLETED	58	0	0
NOT COMPLETED	5	0	0
Period Title: Open Label Maintenance Phase
STARTED	0	25	26
COMPLETED	0	18	20
NOT COMPLETED	0	7	6

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.
Overall Participants	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.8 (1.64)
Age, Customized (participants) [Number]
12 to 14 years	24 38.7%
15 to 17 years	38 61.3%
Sex: Female, Male (Count of Participants)
Female	24 38.7%
Male	38 61.3%
Race/Ethnicity, Customized (participants) [Number]
Not Hispanic or Latino	16 25.8%
Hispanic or Latino	6 9.7%
Not Collected outside the United States	40 64.5%
Race/Ethnicity, Customized (participants) [Number]
Black or African American	1 1.6%
White	61 98.4%
Region of Enrollment (participants) [Number]
United States	22 35.5%
Portugal	4 6.5%
Poland	34 54.8%
Mexico	2 3.2%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	165.5 (9.68)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	61.86 (17.060)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	22.34 (5.086)
Smoking Classification (participants) [Number]
Never smoked	61 98.4%
Current smoker	1 1.6%
Ex-smoker	0 0%
Helicobacter pylori (H. pylori) Status (participants) [Number]
Positive	0 0%
Negative	61 98.4%
Unknown	1 1.6%
Erosive Esophagitis Present (participants) [Number]
Yes	62 100%
No	0 0%
Baseline EE Grade (LA Classification) (participants) [Number]
A	34 54.8%
B	26 41.9%
C	1 1.6%
D	1 1.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period
Description	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set includes all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks.

Arm/Group Title	Healing Phase: Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
Measure Participants	62
Diarrhoea	6.5 10.5%
Nasopharyngitis	6.5 10.5%
Headache	12.9 20.8%
Oropharyngeal pain	8.1 13.1%

2. Primary Outcome

Title	Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period
Description	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.
Time Frame	From Week 8 to Week 24

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.

Arm/Group Title	Maintenance Phase: Dexlansoprazole 30 mg	Maintenance Phase: Placebo
Arm/Group Description	Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.	Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Measure Participants	25	26
Abdominal pain	12.0 19.4%	11.5 NaN
Abdominal pain upper	4.0 6.5%	7.7 NaN
Erosive oesophagitis	4.0 6.5%	7.7 NaN
Diarrhoea	0.0 0%	7.7 NaN
Pyrexia	0.0 0%	7.7 NaN
Nasopharyngitis	12.0 19.4%	15.4 NaN
Pharyngitis	12.0 19.4%	0.0 NaN
Sinusitis	12.0 19.4%	0.0 NaN
Upper respiratory tract infection	8.0 12.9%	0.0 NaN
Bronchitis	8.0 12.9%	3.8 NaN
Headache	24.0 38.7%	15.4 NaN
Insomnia	8.0 12.9%	0.0 NaN

3. Secondary Outcome

Title	Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8
Description	Healing of EE was assessed by endoscopy.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.

Arm/Group Title	Healing Phase: Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
Measure Participants	58
Number (95% Confidence Interval) [percentage of participants]	87.9 141.8%

4. Secondary Outcome

Title	Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24
Description	Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.
Time Frame	From Week 8 to Week 24

Outcome Measure Data

Analysis Population Description

Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.

Arm/Group Title	Maintenance Phase: Dexlansoprazole 30 mg	Maintenance Phase: Placebo
Arm/Group Description	Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.	Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Measure Participants	22	24
Number (95% Confidence Interval) [percentage of participants]	81.8 131.9%	58.3 NaN

5. Secondary Outcome

Title	Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment
Description	Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.

Arm/Group Title	Healing Phase: Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
Measure Participants	62
Mean (Standard Deviation) [percent of days]	59.6 (30.46)

6. Secondary Outcome

Title	Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24
Description	The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.
Time Frame	Weeks 8 to 24

Outcome Measure Data

Analysis Population Description

Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.

Arm/Group Title	Maintenance Phase: Dexlansoprazole 30 mg	Maintenance Phase: Placebo
Arm/Group Description	Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.	Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Measure Participants	24	26
Mean (Standard Deviation) [percent of days]	76.7 (29.82)	68.9 (26.04)

Adverse Events

Time Frame	Up to 24 Weeks
Adverse Event Reporting Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Arm/Group Title	Healing Phase: Dexlansoprazole 60 mg		Maintenance Phase: Dexlansoprazole 30 mg		Maintenance Phase: Placebo
Arm/Group Description	Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.		Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.		Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
All Cause Mortality
	Healing Phase: Dexlansoprazole 60 mg		Maintenance Phase: Dexlansoprazole 30 mg		Maintenance Phase: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Healing Phase: Dexlansoprazole 60 mg		Maintenance Phase: Dexlansoprazole 30 mg		Maintenance Phase: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/62 (1.6%)		2/25 (8%)		1/26 (3.8%)
Gastrointestinal disorders
Erosive oesophagitis	0/62 (0%)		1/25 (4%)		0/26 (0%)
Infections and infestations
H1N1 influenza	0/62 (0%)		0/25 (0%)		1/26 (3.8%)
Nervous system disorders
Convulsion	0/62 (0%)		1/25 (4%)		0/26 (0%)
Psychiatric disorders
Substance abuse	1/62 (1.6%)		0/25 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Healing Phase: Dexlansoprazole 60 mg		Maintenance Phase: Dexlansoprazole 30 mg		Maintenance Phase: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/62 (38.7%)		14/25 (56%)		11/26 (42.3%)
Gastrointestinal disorders
Diarrhoea	4/62 (6.5%)		0/25 (0%)		2/26 (7.7%)
Abdominal pain	3/62 (4.8%)		3/25 (12%)		3/26 (11.5%)
Abdominal pain upper	1/62 (1.6%)		1/25 (4%)		2/26 (7.7%)
Erosive oesophagitis	0/62 (0%)		1/25 (4%)		2/26 (7.7%)
General disorders
Pyrexia	0/62 (0%)		0/25 (0%)		2/26 (7.7%)
Infections and infestations
Nasopharyngitis	4/62 (6.5%)		3/25 (12%)		4/26 (15.4%)
Bronchitis	1/62 (1.6%)		2/25 (8%)		1/26 (3.8%)
Pharyngitis	3/62 (4.8%)		3/25 (12%)		0/26 (0%)
Sinusitis	1/62 (1.6%)		3/25 (12%)		0/26 (0%)
Upper respiratory tract infection	2/62 (3.2%)		2/25 (8%)		0/26 (0%)
Nervous system disorders
Headache	8/62 (12.9%)		6/25 (24%)		4/26 (15.4%)
Psychiatric disorders
Insomnia	1/62 (1.6%)		2/25 (8%)		0/26 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	5/62 (8.1%)		1/25 (4%)		1/26 (3.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.