Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

Study Description

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Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Esophagitis, Reflux; Esophagitis, Peptic	Drug: Dexlansoprazole MR; Drug: Placebo	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	451 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
Study Start Date :	January 2006
Actual Primary Completion Date :	November 2006
Actual Study Completion Date :	November 2006

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Dexlansoprazole MR 60 mg QD	Drug: Dexlansoprazole MR; Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.; Other Names: TAK-390MR; Dexilant; Kapidex
Experimental: Dexlansoprazole MR 90 mg QD	Drug: Dexlansoprazole MR; Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.; Other Names: TAK-390MR; Kapidex; Dexilant
Placebo Comparator: Placebo	Drug: Placebo; Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 6 months ]
   Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
2. Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method [ Time Frame: 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 :

1. Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 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.
2. Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 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
3. Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 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.
4. Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.
• 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.

Contacts and Locations

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  Show 100 Study Locations

Sponsors and Collaborators

Takeda

Investigators

Study Chair:	Medical Director	Takeda

More Information

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Additional Information:

For the Dexilant package insert refer to this link 

For the FDA Safety Alerts and Recalls refer to this link 

Publications of Results:

Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT00255151 History of Changes
Other Study ID Numbers:	T-EE04-087; U1111-1114-1767 ( Registry Identifier: WHO )
First Posted:	November 17, 2005
Results First Posted:	August 28, 2009
Last Update Posted:	February 3, 2012
Last Verified:	February 2012

Keywords provided by Takeda:

Erosive Esophagitis

Additional relevant MeSH terms:

Esophagitis; Esophagitis, Peptic; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases	Stomach Diseases; Dexlansoprazole; Lansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action