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NCT00251719 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
A Phase 3 study of Esophagitis, Reflux and Esophagitis, Peptic, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,054
- Enrollment target
- 20
- Study locations
NCT00251719: Completed Phase 3 study of Esophagitis, Reflux and Esophagitis, Peptic, sponsored by Takeda.
NCT00251719 is a Phase 3 study of Esophagitis, Reflux and Esophagitis, Peptic that has completed, run by Takeda. The registered enrollment target is 2,054 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (166% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00251719, a Phase 3 study of Esophagitis, Reflux and Esophagitis, Peptic, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,054 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.
Primary Outcome
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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.
Conditions Studied
Interventions
- DRUG Lansoprazole
- DRUG Dexlansoprazole MR
Study Locations (20)
California
- - Azusa
- - Carmichael
- - Cypress
- - Fresno
- - Los Angeles
- - Modesto
- - Newport Beach
- - Oakland
- - Orange
- - San Diego
- - Santa Maria
Alabama
- - Anniston
- - Hueytown
- - Huntsville
- - Tallassee
- - Tuscaloosa
Arkansas
- - Little Rock
- - North Little Rock
Arizona
- - Tucson
Colorado
- - Littleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,054 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
What the finished NCT00251719 record still lists
NCT00251719 is an interventional study that assigns participants to a tested intervention. Its 2,054 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 (166% higher).
The record links to 2 conditions, with Esophagitis, Reflux appearing as the primary indexed condition, and to 2 interventions - of which Lansoprazole is the first listed.
NCT00251719 names 20 study sites across 5 states, led by California, Alabama, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00251719 about?
NCT00251719 is a clinical study titled "Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis". This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.
What is the current status of trial NCT00251719?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,054 participants. The study started on 2005-12. Estimated completion is 2007-01.
What conditions does trial NCT00251719 study?
This clinical trial studies the following conditions: Esophagitis, Reflux, Esophagitis, Peptic.
What interventions are being tested in trial NCT00251719?
The interventions under investigation include: Lansoprazole (DRUG), Dexlansoprazole MR (DRUG).
Who is sponsoring clinical trial NCT00251719?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00251719 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00251719's enrollment target sits among peer trials
2,054 99th of 2000 higher than 1,902 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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