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

Takeda

Status and phase

Completed

Phase 3

Conditions

Esophagitis, Peptic

Esophagitis, Reflux

Treatments

Drug: Dexlansoprazole MR

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00321737

T-EE05-135

U1111-1113-9433 (Registry Identifier)

2006-000419-90 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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 60 mg) with that of placebo, in maintaining healing of EE.

Enrollment

445 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.