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Adolescent Fibromyalgia Study

NCT01020474 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2021-01-28

Study results available
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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

  • Fibromyalgia

Interventions

DRUG

placebo

matching placebo capsules twice daily.

DRUG

pregabalin (Lyrica)

75-450mg/day pregabalin dose optimised at start of study

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Czechia
  • India
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020474 on ClinicalTrials.gov