Trials / Completed
CompletedNCT00843024
Migraine Study in Adolescent Patients
TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 589 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
Detailed description
The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a \~25 week period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sumatriptan and Naproxen Sodium | Sumatriptan succinate and naproxen sodium |
| DRUG | Placebo | Placebo to match |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2010-05-01
- Completion
- 2010-06-01
- First posted
- 2009-02-13
- Last updated
- 2017-01-18
- Results posted
- 2011-05-09
Locations
79 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00843024. Inclusion in this directory is not an endorsement.