Status:
COMPLETED
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Lead Sponsor:
Takeda
Conditions:
Esophagitis, Reflux
Esophagitis, Peptic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 an...
Eligibility Criteria
Inclusion
- Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.
Exclusion
- Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study
- Use of antacids (except for study supplied) throughout the study.
- Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
- Need for continuous anticoagulant therapy.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00255164
Start Date
January 1 2006
End Date
November 1 2006
Last Update
February 3 2012
Active Locations (96)
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1
Alabaster, Alabama, United States
2
Birmingham, Alabama, United States
3
Huntsville, Alabama, United States
4
Phoenix, Arizona, United States