Trials / Completed
CompletedNCT01020474
Adolescent Fibromyalgia Study
A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | placebo | matching placebo capsules twice daily. |
| DRUG | pregabalin (Lyrica) | 75-450mg/day pregabalin dose optimised at start of study |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2009-11-25
- Last updated
- 2021-01-28
- Results posted
- 2015-06-25
Locations
36 sites across 4 countries: United States, Czechia, India, Taiwan
Source: ClinicalTrials.gov record NCT01020474. Inclusion in this directory is not an endorsement.