Efficacy and Safety 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, multicenter, 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 (this posting, NCT00241745) and T-GD04-083 (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 Once-Daily (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· 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. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy. 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 Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

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