Phase 3
N=445
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Esophagitis, Reflux · Esophagitis, Peptic
Bottom Line
View on ClinicalTrials.gov: NCT00321737 ↗Enrolled (actual)
445
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; 66.4 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
- May 2007
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; 66.4 | <0.00001 sig |
| PRIMARY Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method |
27.2; 74.9; 82.5 | <0.00001 sig |
| SECONDARY Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. |
28.6; 96.1; 90.9 | <0.00001 sig |
| SECONDARY Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. |
36.0; 83.3; 78.4 | — |
| SECONDARY Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. |
71.7; 98.9; 96.2 | <0.00001 sig |
| SECONDARY Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. |
57.7; 89.3; 86.0 | — |
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).
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00321737). 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.