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NCT00251758 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 908
- Enrollment target
NCT00251758: Completed Phase 3 study, sponsored by Takeda.
NCT00251758 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 908 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00251758, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 908 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Dexlansoprazole MR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 908 participants |
| Start Date | 2005-12 |
| Est. Completion | 2006-05 |
| Phase | Phase 3 |
What the finished NCT00251758 record still lists
NCT00251758 is an interventional study that assigns participants to a tested intervention. The registered 908 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00251758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00251758 about?
NCT00251758 is a clinical study titled "Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn". The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
What is the current status of trial NCT00251758?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 908 participants. The study started on 2005-12. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00251758?
The interventions under investigation include: Placebo (DRUG), Dexlansoprazole MR (DRUG).
Who is sponsoring clinical trial NCT00251758?
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 NCT00251758's enrollment target sits among peer trials
908 347th of 2000 higher than 1,654 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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