Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
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| ClinicalTrials.gov Identifier: NCT00255151 |
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Recruitment Status :
Completed
First Posted : November 17, 2005
Results First Posted : August 28, 2009
Last Update Posted : February 3, 2012
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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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 |
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 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 |
Resource links provided by the National Library of Medicine
| 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:
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| Experimental: Dexlansoprazole MR 90 mg QD |
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Other Names:
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| Placebo Comparator: Placebo |
Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months. |
Primary Outcome Measures :
- 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.
- 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 :
- 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.
- 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
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255151
Locations
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Sponsors and Collaborators
Takeda
Investigators
| Study Chair: | Medical Director | Takeda |
Additional Information:
Publications of Results:
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT00255151 |
| Other Study ID Numbers: |
T-EE04-087 U1111-1114-1767 ( Registry Identifier: WHO ) |
| First Posted: | November 17, 2005 Key Record Dates |
| Results First Posted: | August 28, 2009 |
| Last Update Posted: | February 3, 2012 |
| Last Verified: | February 2012 |
Keywords provided by Takeda:
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Erosive Esophagitis |
Additional relevant MeSH terms:
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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 |