Phase 3
N=451
Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
Esophagitis, Reflux · Esophagitis, Peptic
Bottom Line
View on ClinicalTrials.gov: NCT00255151 ↗Enrolled (actual)
451
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. — 14.3; 66.4; 64.5 Percentage of Subjects — p=<0.00001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexlansoprazole MR (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. |
14.3; 66.4; 64.5 | <0.00001 sig |
| PRIMARY Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method |
25.7; 86.6; 82.1 | <0.00001 sig |
| SECONDARY Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. |
19.2; 95.8; 94.4 | <0.00001 sig |
| SECONDARY Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. |
29.5; 79.7; 79.2 | — |
| SECONDARY Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. |
50.0; 98.3; 97.1 | <0.00001 sig |
| SECONDARY Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. |
48.3; 87.1; 85.4 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00255151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.