Trials / Completed
CompletedNCT00255164
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 451 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).
Detailed description
This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis. Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (this study, NCT00255164) and T-EE04-087 (NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexlansoprazole MR | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months. |
| DRUG | Dexlansoprazole MR | Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months. |
| DRUG | Placebo | Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months. |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2005-11-17
- Last updated
- 2012-02-03
- Results posted
- 2009-08-28
Locations
96 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00255164. Inclusion in this directory is not an endorsement.