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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 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 48 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00303264
The ClinicalTrials.gov registry entry for NCT00303264 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nexium (esomeprazole) is the first listed.
NCT00303264 reports 0 study locations.
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.
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