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NCT00434083 · ClinicalTrials.gov registry record · Phase 3
To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches
A Phase 3 study, sponsored by POZEN.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
NCT00434083 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 1,200 participants.
The verdict
NCT00434083, a Phase 3 study, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
Study Summary
* to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine * to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and * to evaluate the safety of the Trexima.
Interventions
- DRUG sumatriptan
- DRUG naproxen sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00434083
The ClinicalTrials.gov registry entry for NCT00434083 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is POZEN, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which sumatriptan is the first listed.
NCT00434083 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00434083 about?
NCT00434083 is a clinical study titled "To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches". * to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine * to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen s...
What is the current status of trial NCT00434083?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2004-07. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00434083?
The interventions under investigation include: sumatriptan (DRUG), naproxen sodium (DRUG).
Who is sponsoring clinical trial NCT00434083?
This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.
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