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NCT00387881 · ClinicalTrials.gov registry record · Phase 3
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 679
- Enrollment target
NCT00387881: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00387881 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 679 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00387881, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 679 participants
- Enrollment target
Study Summary
This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Primary Outcome
Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
Interventions
- DRUG Placebo
- DRUG sumatriptan succinate / naproxen sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 679 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00387881 record still lists
NCT00387881 is an interventional study that assigns participants to a tested intervention. The registered 679 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00387881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00387881 about?
NCT00387881 is a clinical study titled "TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)". This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
What is the current status of trial NCT00387881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 679 participants. The study started on 2006-09. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00387881?
The interventions under investigation include: Placebo (DRUG), sumatriptan succinate / naproxen sodium (DRUG).
Who is sponsoring clinical trial NCT00387881?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00387881's enrollment target sits among peer trials
679 536th of 2000 higher than 1,465 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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