Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Placebo; Drug: Dexlansoprazole MR

• Registration Number: NCT00251758
• Lead Sponsor: Takeda

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-10
• Study Start: 2005-12
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Results First Submitted: 2009-02-26
• Results First Submitted QC: 2009-03-20
• Results First Posted: 2009-03-23
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-12
• Last Update Posted: 2010-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 908

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR	-
Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR	-

Primary Outcome Measures

Name	Time	Method
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median	4 weeks	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.
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median	4 weeks	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.
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean	4 weeks	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.