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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 173 participants.
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). \[Study 1 of 2\]
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00383162
The ClinicalTrials.gov registry entry for NCT00383162 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00383162 reports 0 study locations.
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.
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