Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

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 Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive 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 Dexlansoprazole MR (30 mg QD and 60 mg QD) 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 nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US 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.

Official Title
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A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive 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 identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn). Subject has a history of episodes of heartburn for 6 months or longer prior to Screening. Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1. Exclusion Criteria: Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures. Subjects with erosive esophagitis (EE) as shown by endoscopy. Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome. Subject has abnormal laboratory values. Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose. Subject known to have acquired immunodeficiency syndrome (AIDS). Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid. Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate. 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. Subjects who cannot discontinue the use of misoprostol or prokinetics Need for continuous anticoagulant therapy. Females who are pregnant or lactating. History of gastrointestinal surgery except for simple oversew of ulcer. History of cancer within 3 years prior to screening. Subject has participated in a previous Dexlansoprazole study. 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 30 mg QD<br> | Drug: Dexlansoprazole MR<br>* Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.<br>* Other names: Dexilant;|
| 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;|
| 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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Gastroesophageal Reflux Disease(GERD), Heartburn