Fibromyalgia | Adolescent Fibromyalgia Study
Fibromyalgia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Diagnosis of fibromyalgia - 12-17 years of age Exclusion Criteria: - Patients with other pain conditions - Previous treatment with pregabalin - Patients taking excluded medication
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:placebomatching placebo capsules twice daily.
Drug:pregabalin (Lyrica)75-450mg/day pregabalin dose optimised at start of study
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: May 2010
Completed Date: December 2014
Phase: Phase 4
Primary Outcome: Change From Baseline to Week 15 in Mean Pain Diary Score
Secondary Outcome: Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Study sponsors, principal investigator, and references
Principal Investigator: Pfizer CT.gov Call Center
Lead Sponsor: Pfizer