NCT00251745

Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 908 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
DRUG	Placebo	Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2005-11-10
• Last updated: 2011-04-28
• Results posted: 2009-03-23

Locations

95 sites across 1 country: United States