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)
Public ClinicalTrials.gov record NCT00383162. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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). \[Study 1 of 2\]
Study identification
- NCT ID
- NCT00383162
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 173 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2006
- Primary completion
- Sep 30, 2007
- Completion
- Sep 30, 2007
- Last update posted
- Feb 1, 2017
2006 – 2007
United States locations
- U.S. sites
- 26
- U.S. states
- 13
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Fresno | California | 93720 | — |
| GSK Investigational Site | Newport Beach | California | 92660 | — |
| GSK Investigational Site | Santa Monica | California | 90404 | — |
| GSK Investigational Site | Walnut Creek | California | 94596 | — |
| GSK Investigational Site | Fairfield | Connecticut | 06824 | — |
| GSK Investigational Site | Stamford | Connecticut | 06902 | — |
| GSK Investigational Site | Aventura | Florida | 33180 | — |
| GSK Investigational Site | Tallahassee | Florida | 32308 | — |
| GSK Investigational Site | Tampa | Florida | 33609 | — |
| GSK Investigational Site | Chicago | Illinois | 60614 | — |
| GSK Investigational Site | Northbrook | Illinois | 60062 | — |
| GSK Investigational Site | South Bend | Indiana | 46601 | — |
| GSK Investigational Site | Lenexa | Kansas | 66214 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Omaha | Nebraska | 68144 | — |
| GSK Investigational Site | Orchard Park | New York | 14127 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27401 | — |
| GSK Investigational Site | Matthews | North Carolina | 28105 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Tabor City | North Carolina | 28463 | — |
| GSK Investigational Site | Fargo | North Dakota | 58103 | — |
| GSK Investigational Site | Dallas | Texas | 75214 | — |
| GSK Investigational Site | Houston | Texas | 77004 | — |
| GSK Investigational Site | Alexandria | Virginia | 22304 | — |
| GSK Investigational Site | Roanoke | Virginia | 24013 | — |
| GSK Investigational Site | Virginia Beach | Virginia | 23452 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00383162, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2017 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00383162 live on ClinicalTrials.gov.