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NCT00383162 · ClinicalTrials.gov registry record · Phase 3
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
NCT00383162: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00383162 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 173 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00383162, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). \[Study 1 of 2\]
Primary Outcome
Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.
Interventions
- DRUG Placebo
- DRUG Combination Product (sumatriptan succinate / naproxen sodium)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-10 |
| Phase | Phase 3 |
What the finished NCT00383162 record still lists
NCT00383162 is an interventional study that assigns participants to a tested intervention. The registered 173 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00383162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00383162 about?
NCT00383162 is a clinical study titled "A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)". This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will trea...
What is the current status of trial NCT00383162?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2006-11. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00383162?
The interventions under investigation include: Placebo (DRUG), Combination Product (sumatriptan succinate / naproxen sodium) (DRUG).
Who is sponsoring clinical trial NCT00383162?
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 NCT00383162's enrollment target sits among peer trials
173 1445th of 2000 higher than 553 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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