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

Phase 3

Completed

• Conditions: Esophagitis, Reflux; Esophagitis, Peptic
• Interventions: Drug: Dexlansoprazole MR; Drug: Placebo

• Registration Number: NCT00321737
• Lead Sponsor: Takeda

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

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-04
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Results First Submitted: 2009-02-20
• Results First Submitted QC: 2009-07-20
• Results First Posted: 2009-08-28
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexlansoprazole MR 30 mg QD	Dexlansoprazole MR	-
Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.	6 months	Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method	6 months	Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.

Secondary Outcome Measures

Name	Time	Method
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.	6 months	The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.	6 months	The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.	6 months	The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.	6 months	The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.