Overview

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
Dexlansoprazole
Lansoprazole
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.