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NCT00321984 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 947
- Enrollment target
NCT00321984: Completed Phase 3 study, sponsored by Takeda.
NCT00321984 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 947 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00321984, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 947 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive 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 | 947 participants |
| Start Date | 2006-06 |
| Est. Completion | 2006-12 |
| Phase | Phase 3 |
What the finished NCT00321984 record still lists
NCT00321984 is an interventional study that assigns participants to a tested intervention. The registered 947 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 (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00321984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00321984 about?
NCT00321984 is a clinical study titled "Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease". The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).
What is the current status of trial NCT00321984?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 947 participants. The study started on 2006-06. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00321984?
The interventions under investigation include: Placebo (DRUG), Dexlansoprazole MR (DRUG).
Who is sponsoring clinical trial NCT00321984?
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 NCT00321984's enrollment target sits among peer trials
947 334th of 2000 higher than 1,667 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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