Status:
COMPLETED
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo 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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE)...
Detailed Description
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and...
Eligibility Criteria
Inclusion
- Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (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.
- Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
- Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
- Need for continuous anticoagulant therapy.
- Evidence of uncontrolled systemic disease.
- Subjects who have participated in either maintenance study (T-EE04-086 \[NCT00255164\] or T-EE04-087 \[NCT00255151\]).
- Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT00321737
Start Date
May 1 2006
End Date
May 1 2007
Last Update
February 3 2012
Active Locations (98)
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Huntsville, Alabama, United States
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Tuscon, Arizona, United States
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Anaheim, California, United States
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Azusa, California, United States