Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain 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

NCT00255151

U1111-1114-1767 (Registry Identifier)

T-EE04-087

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) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Full 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 (NCT00255164) and T-EE04-087 (this study, 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.

Enrollment: 451 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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451 participants in 3 patient groups, including a placebo group

Dexlansoprazole MR 60 mg QD

Experimental group

Treatment:

Drug: Dexlansoprazole MR

Drug: Dexlansoprazole MR

Dexlansoprazole MR 90 mg QD

Experimental group

Treatment:

Drug: Dexlansoprazole MR

Drug: Dexlansoprazole MR

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo