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NCT00303264 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00303264: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT00303264 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00303264, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
"Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea, retching and vomiting. These symptoms may present with or without the co-existence of symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled out and the source of the pain is unknown. The standard of care for most patients presenting with dyspeptic symptoms has been with proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some success in these patients, there is a significant population of patients whose dyspeptic symptoms are not adequately treated with PPI's alone. The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated adequately with PPI's.
Interventions
- DRUG Nexium (esomeprazole)
- DRUG dexloxiglumide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-05 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
What the finished NCT00303264 record still lists
NCT00303264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Nexium (esomeprazole) is the first listed.
NCT00303264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00303264 about?
NCT00303264 is a clinical study titled "The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.". "Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea, retching and vomiting. These symptoms may present with or without the co-existence of symptoms of heartburn or gas...
What is the current status of trial NCT00303264?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2006-05. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00303264?
The interventions under investigation include: Nexium (esomeprazole) (DRUG), dexloxiglumide (DRUG).
Who is sponsoring clinical trial NCT00303264?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00303264's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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