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NCT00251693 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,038
- Enrollment target
NCT00251693: Completed Phase 3 study, sponsored by Takeda.
NCT00251693 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 2,038 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (164% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00251693, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,038 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
Primary Outcome
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
Interventions
- DRUG Lansoprazole
- DRUG Dexlansoprazole MR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,038 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
What the finished NCT00251693 record still lists
NCT00251693 is an interventional study that assigns participants to a tested intervention. Its 2,038 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (164% higher).
The record links to 0 conditions, and to 2 interventions - of which Lansoprazole is the first listed.
NCT00251693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00251693 about?
NCT00251693 is a clinical study titled "Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis". The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
What is the current status of trial NCT00251693?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,038 participants. The study started on 2005-12. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00251693?
The interventions under investigation include: Lansoprazole (DRUG), Dexlansoprazole MR (DRUG).
Who is sponsoring clinical trial NCT00251693?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00251693's enrollment target sits among peer trials
2,038 100th of 2000 higher than 1,901 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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