Trials / Completed
CompletedNCT01544114
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 12 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
Detailed description
Study with completed results acquired from Horizon in 2024.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VIMOVO 250/20 | 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months |
| DRUG | VIMOVO 375/20 | 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months |
| DRUG | VIMOVO 500/20 | 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2012-03-05
- Last updated
- 2024-12-17
- Results posted
- 2017-10-04
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01544114. Inclusion in this directory is not an endorsement.