Pregabalin In Adolescent Patients With Fibromyalgia
Phase 3
Completed
- Conditions
- Health Condition 1: null- Fibromyalgia
- Registration Number
- CTRI/2010/091/006072
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 162
Inclusion Criteria
1.Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.
Exclusion Criteria
1.Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoint- Pain Numeric Rating Scale (NRS)Timepoint: 6 month
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable