Trials / Completed
CompletedNCT00442221
The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
An Open-Label, Repeat Dose Study Of The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (planned)
- Sponsor
- POZEN · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines
Detailed description
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines, with an optional second dose at least 2 hours following the first dose, if needed. Combo Formulation will be administered on average at least twice per month for 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sumatriptan and Naproxen sodium |
Timeline
- Start date
- 2004-05-01
- Completion
- 2004-08-01
- First posted
- 2007-03-01
- Last updated
- 2007-03-01
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00442221. Inclusion in this directory is not an endorsement.