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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.

Conditions
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Esophagitis, Reflux, Esophagitis, Peptic

Intervention / Treatment
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* Drug: Dexlansoprazole MR
* Drug: Dexlansoprazole MR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexlansoprazole MR 30 mg QD<br> | Drug: Dexlansoprazole MR<br>* Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.<br>* Other names: Dexilant;|
| Experimental: Dexlansoprazole MR 60 mg QD<br> | Drug: Dexlansoprazole MR<br>* Dexlansoprazole MR 60 mg, orally, once daily for up to six months.<br>* Other names: Dexilant;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. | 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. | 6 months | 
| Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. | 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. | 6 months | 
| Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. | 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. | 6 months | 
| Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erosive Esophagitis