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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?

Fibromyalgia

Study Interventions

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

Study Arms

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.

Placebo

drug-pregabalin

Study Status

Completed

Start Date: May 2010

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01020474

Discuss Lyrica