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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: Completed Phase 3 study, sponsored by POZEN.
NCT00434083 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 1,200 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00434083 record still lists
NCT00434083 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 2 interventions - of which sumatriptan is the first listed.
NCT00434083 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00434083's enrollment target sits among peer trials
1,200 220th of 2000 higher than 1,773 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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