NCT00255190

Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 591 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.

Detailed description

This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions. Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study. After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months. Approximately 200 study sites in the U.S. will participate. For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-11-17
• Last updated: 2016-07-27
• Results posted: 2009-08-12

Locations

181 sites across 1 country: United States