Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02351960
• Collaborator: (none)
• Enrollment: 296
• Locations: 10
• Arms: 2
• Actual Duration (Months): 15.8
• Patients Per Site: 29.6
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of symptom control in gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Dexlansoprazole	Phase 4

Detailed Description

The drug being tested in this study is called dexlansoprazole. A dual delayed release formulation of dexlansoprazole, referred to as dexlansoprazole modified release (dexlansoprazole MR) was tested to treat people who have gastroesophageal reflux disease (GERD). This study looked at the healing of the esophageal lining of the GERD participants who took dexlansoprazole MR.

The study enrolled 296 patients. Participants were assigned to two study groups based on the endoscopy screening procedures to receive treatments as follows:

• Dexlansoprazole 30 mg to participants with non-erosive reflux disease (NERD)

• Dexlansoprazole 60 mg to participants with erosive esophagitis (EE)

All participants were asked to take one capsule in the morning each day throughout the study. All participants were asked to record the presence and maximum severity of daytime and nighttime heartburn and regurgitation symptoms during screening and, if assigned to a treatment group, throughout the duration of the study using the supplied paper diary.

This multi-center trial was conducted in Asia (Hong Kong, Taiwan, South Korea). The overall time to participate in this study was up to 8 weeks. Participants would make up to 3 visits to the clinic, and would be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 296 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 4, Open-Label Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole
• Actual Study Start Date: Mar 19, 2015
• Actual Primary Completion Date: Jun 22, 2016
• Actual Study Completion Date: Jul 13, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexlansoprazole 30 mg Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Drug: Dexlansoprazole; Dexlansoprazole capsules
Experimental: Dexlansoprazole 60 mg Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).	Drug: Dexlansoprazole; Dexlansoprazole capsules

Outcome Measures

Primary Outcome Measures

1. Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants [Up to Week 4]

   NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.

2. Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants [Up to Week 8]

   EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated.

Secondary Outcome Measures

1. Percentage of 24-hour Heartburn-free Days [Up to 4 weeks for NERD participants and up to 8 weeks for EE participants]

   Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries.

2. Percentage of 24-hour Acid Regurgitation-free Days [Up to 4 weeks for NERD participants and up to 8 weeks for EE participants]

   Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries.

3. Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation [Up to 4 weeks for NERD participants and up to 8 weeks for EE participants]

   Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries.

4. Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn [Up to 4 weeks for NERD participants and up to 8 weeks for EE participants]

   Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries.

5. Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation [Up to 4 weeks for NERD participants and up to 8 weeks for EE participants]

   Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries.

6. Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms [Up to 4 weeks for NERD participants and up to 8 weeks for EE participants]

   The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP).

7. Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus [Week 8]

   Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: -

1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements

2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any procedures

3. Has persistent typical gastroesophageal reflux disease (GERD) symptoms (heartburn and/or acid regurgitation) for at least 6 months and a frequency of GERD symptoms is at least 4 days within the past 7 days prior to the screening visit

4. Meets one of the following diagnoses verified by the screening endoscopy

5. Has macroscopically normal esophageal mucosa on endoscopy and may thereby be eligible for assignment to the nonerosive reflux disease (NERD) study group

6. Has evidence of erosive esophageal reflux disease on endoscopy, Los Angeles (LA) classification grades B-D, and thereby may be eligible for assignment to the erosive esophagitis (EE) study group

7. Is able and willing to record GERD symptoms in a subject diary and has completed the diary at least for 7 consecutive days during the screening period

8. 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 throughout the duration of the study and for 30 days after last dose

9. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study

10. All female participants of childbearing potential must have a negative urine pregnancy test at Screening and a negative urine pregnancy test at Day -1. Participants who have had a bilateral tubal ligation, hysterectomy or are post-menopausal (the absence of menses for 1-2 years with a Follicle-Stimulating Hormone [FSH] level >40 IU/L or absence of menses for >2 years) are not required to use birth control

Exclusion Criteria:

1. Has received any investigational compound within 30 days prior to Screening

2. Known hypersensitivity to any proton pump inhibitor (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of dexlansoprazole

3. Use of a H2 blocker or a PPI other than dexlansoprazole during screening and throughout the study. Previous use of Dexlansoprazole before screening

4. Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

5. Active gastric or duodenal ulcers within 4 weeks of the first dose of study drug

6. History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)

7. Co-existing diseases affecting the esophagus, (eg, esophageal varices, scleroderma, viral, fungal infection or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus

8. Chronic use (>12 doses/month) of non-;steroidal anti-inflammatory drugs (NSAIDs) including COX 2 NSAIDs within 30 days prior to screening period and throughout the study, however, low dose aspirin up to 325 mg per day is allowed

9. In the judgment of the investigator, participant has clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening

10. Has a history or clinical manifestations of significant organ failure which would preclude their successful completion of the study

11. Participants using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study

12. Participants with known biliary disease

13. Participants with the need for continuous anticoagulant therapy

14. Participants with cancer (except basal cell and squamous cell carcinoma of the skin) within 3 years prior to Screening

15. Any condition that may require inpatient surgery during the course of the study

16. Has abnormal laboratory values that suggest a clinically significant underlying disease or condition that may prevent the subject from entering the study; or subject with the following lab abnormalities: Creatinine >1.5 mg/dL, Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >2.0X the upper limits of normal, or Total Bilirubin >2.0 mg/dL with AST/ALT elevated above normal values

17. Known to have acquired immunodeficiency syndrome (AIDS)

18. Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition

19. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer

20. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of endoscopy

21. Has received blood products within 3 months prior to the first dose of study drug 23. History of alcohol abuse [>21 units (1 unit = 12 oz beer, 1.5 oz hard liquor, or 5 oz wine) per week] or illegal drug use or drug addiction in the 12 months prior to Screening 24. Participants who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason 25. is required to take excluded medications 26. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period 27. If male, the participant intends to donate sperm during the course of this study or for 30 days thereafter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Shatin	New Territories	Hong Kong
2		Gyeonggi-do		Korea, Republic of	463-707
3		Gyeonggi-do		Korea, Republic of
4		Seoul		Korea, Republic of	137-701
5		Seoul		Korea, Republic of
6		Kaoshiung		Taiwan
7		Taichung		Taiwan
8		Tainan		Taiwan
9		Taipei		Taiwan
10		Taoyuan		Taiwan

Sponsors and Collaborators

• Takeda

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02351960
• Other Study ID Numbers: DEX-P4-001; U1111-1155-8622
• First Posted: Jan 30, 2015
• Last Update Posted: Oct 4, 2017
• Last Verified: May 1, 2017

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

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 12 investigative sites in Hong Kong, South Korea, Taiwan from 19 March 2015 to 13 July 2016.
Pre-assignment Detail	Participants with a diagnosis of non-erosive reflux disease (NERD) were enrolled to receive dexlansoprazole 30 mg and participants with erosive esophagitis (EE) were enrolled to receive dexlansoprazole 60 mg.

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Period Title: Overall Study
STARTED	208	88
COMPLETED	197	76
NOT COMPLETED	11	12

Baseline Characteristics

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg	Total
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).	Total of all reporting groups
Overall Participants	208	88	296
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.6 (13.62)	51.7 (12.51)	52.6 (13.06)
Age, Customized (participants) [Number]
<45 years	60 28.8%	29 33%	89 30.1%
45-<65 years	102 49%	42 47.7%	144 48.6%
≥65 years	46 22.1%	17 19.3%	63 21.3%
Sex: Female, Male (Count of Participants)
Female	72 34.6%	49 55.7%	121 40.9%
Male	136 65.4%	39 44.3%	175 59.1%
Race/Ethnicity, Customized (participants) [Number]
Asian	208 100%	87 98.9%	295 99.7%
Multiracial	0 0%	1 1.1%	1 0.3%
Region of Enrollment (participants) [Number]
Hong Kong	13 6.3%	6 6.8%	19 6.4%
Korea, Republic Of	195 93.8%	12 13.6%	207 69.9%
Taiwan, Province Of China	0 0%	70 79.5%	70 23.6%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	60.26 (11.619)	68.84 (14.986)	64.55 (13.302)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	161.5 (8.43)	165.0 (9.65)	163.25 (9.04)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.00 (3.305)	25.11 (4.160)	24.05 (3.732)
BMI categories (participants) [Number]
<25 kg/m^2	158 76%	46 52.3%	204 68.9%
25-<30 kg/m^2	43 20.7%	33 37.5%	76 25.7%
≥30 kg/m^2	7 3.4%	9 10.2%	16 5.4%
Smoking History (participants) [Number]
Never Smoked	169 81.3%	61 69.3%	230 77.7%
Current Smoker	15 7.2%	11 12.5%	26 8.8%
Ex-smoker	24 11.5%	16 18.2%	40 13.5%
12-Lead Electrocardiogram (ECG) (participants) [Number]
Within Normal Limits	141 67.8%	55 62.5%	196 66.2%
Abnormal but not Clinically Significant	67 32.2%	33 37.5%	100 33.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants
Description	NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.
Time Frame	Up to Week 4

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.

Arm/Group Title	Dexlansoprazole 30 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
Measure Participants	207
Median (Full Range) [percentage of days]	26.92

2. Primary Outcome

Title	Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants
Description	EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Arm/Group Title	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	87
Median (Full Range) [percentage of days]	65.45

3. Secondary Outcome

Title	Percentage of 24-hour Heartburn-free Days
Description	Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries.
Time Frame	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	207	87
Median (Full Range) [percentage of days]	53.85	81.97

4. Secondary Outcome

Title	Percentage of 24-hour Acid Regurgitation-free Days
Description	Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries.
Time Frame	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	207	88
Median (Full Range) [percentage of days]	75.00	88.46

5. Secondary Outcome

Title	Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation
Description	Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries.
Time Frame	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	207	87
Median (Full Range) [percentage of nights]	59.26	83.33

6. Secondary Outcome

Title	Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn
Description	Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries.
Time Frame	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	207	87
Median (Full Range) [percentage of nights]	73.08	92.73

7. Secondary Outcome

Title	Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation
Description	Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries.
Time Frame	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	207	87
Median (Full Range) [percentage of nights]	88.00	92.59

8. Secondary Outcome

Title	Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms
Description	The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP).
Time Frame	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here, 'n' is the number of participants who were analyzed for GERD assessments at specified time points.

Arm/Group Title	Dexlansoprazole 30 mg	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	207	88
Heartburn, None	77 37%	51 58%
Heartburn, Mild	92 44.2%	21 23.9%
Heartburn, Moderate	20 9.6%	3 3.4%
Heartburn, Severe	6 2.9%	1 1.1%
Heartburn, Very Severe	3 1.4%	0 0%
Acid Regurgitation, None	97 46.6%	52 59.1%
Acid Regurgitation, Mild	76 36.5%	21 23.9%
Acid Regurgitation, Moderate	17 8.2%	3 3.4%
Acid Regurgitation, Severe	7 3.4%	0 0%
Acid Regurgitation, Very Severe	1 0.5%	0 0%
Dysphagia, None	169 81.3%	71 80.7%
Dysphagia, Mild	22 10.6%	5 5.7%
Dysphagia, Moderate	6 2.9%	0 0%
Dysphagia, Severe	1 0.5%	0 0%
Dysphagi, Very Severe	0 0%	0 0%
Belching, None	138 66.3%	57 64.8%
Belching, Mild	46 22.1%	17 19.3%
Belching, Moderate	12 5.8%	2 2.3%
Belching, Severe	1 0.5%	0 0%
Belching, Very Severe	1 0.5%	0 0%
Epigastric Pain, None	144 69.2%	58 65.9%
Epigastric Pain, Mild	42 20.2%	18 20.5%
Epigastric Pain, Moderate	9 4.3%	0 0%
Epigastric Pain, Severe	3 1.4%	0 0%
Epigastric Pain, Very Severe	0 0%	0 0%

9. Secondary Outcome

Title	Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus
Description	Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.

Arm/Group Title	Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Measure Participants	88
Number [percentage of participants]	77.3 37.2%

Adverse Events

Time Frame	Day 1 up to 30 days after the last dose of study drug (approximately up to 12 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	Dexlansoprazole 30 mg		Dexlansoprazole 60 mg
Arm/Group Description	Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).		Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
All Cause Mortality
	Dexlansoprazole 30 mg		Dexlansoprazole 60 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexlansoprazole 30 mg		Dexlansoprazole 60 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/208 (0%)		2/88 (2.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	0/208 (0%)		1/88 (1.1%)
Skin and subcutaneous tissue disorders
Urticaria	0/208 (0%)		1/88 (1.1%)
Other (Not Including Serious) Adverse Events
	Dexlansoprazole 30 mg		Dexlansoprazole 60 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/208 (3.4%)		2/88 (2.3%)
Gastrointestinal disorders
Diarrhoea	2/208 (1%)		2/88 (2.3%)
Nervous system disorders
Headache	5/208 (2.4%)		0/88 (0%)

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.