Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).

Detailed Description
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This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a Screening Period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks. Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (NCT00241745) and T-GD04-083 (this posting, NCT00251758), were combined and analyzed as a single larger study, referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.

Official Title
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A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Dexlansoprazole MR
* Drug: Dexlansoprazole MR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn. History of episodes of heartburn for 6 months or longer prior to screening. History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary. Exclusion Criteria: Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study Erosive Esophagitis seen on endoscopy during study screening. Co-existing diseases affecting the esophagus. Abnormal laboratory values that suggest significant clinical disease. Known acquired immunodeficiency syndrome (AIDS) Females pregnant or lactating. History of Alcohol abuse. History of Cancer within 3 years prior to screening. Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors Use of antacids (except for study supplied Gelusil® ) Use of drugs with significant anticholinergic effects Need for continuous anticoagulant (blood thinner) therapy Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexlansoprazole MR 60 mg QD<br> | Drug: Dexlansoprazole MR<br>* Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.<br>* Other names: Dexilant;|
| Experimental: Dexlansoprazole MR 90 mg QD<br> | Drug: Dexlansoprazole MR<br>* Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.<br>* Other names: Dexilant;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. | 4 weeks | 
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. | 4 weeks | 
| Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn