Adolescent Fibromyalgia Study

Viatris

Status and phase: Completed; Phase 4

Conditions: Fibromyalgia

Treatments: Drug: pregabalin (Lyrica); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01020474

A0081180

2010-019521-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

drug-pregabalin

Experimental group

Treatment:

Drug: pregabalin (Lyrica)