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Adolescent Fibromyalgia Study

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

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

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)

Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)

Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)

Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15

Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15

Proportion of Patient Global Impression Change (PGIC) at Week 15

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Bioregeneracni a rehabilitacni centrum, Ricany 25101, Czech Republic

National Taiwan University Hospital, Taipei 100, Taiwan

Krishna Institute of Medical Sciences Ltd, Secunderabad, Andhra Pradesh 500 003, India

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States

Apex Research Institute, Santa Ana, California 92705, United States

Arthritis Associates of South Florida, Delray Beach, Florida 33484, United States

Delray Research Associates, Delray Beach, Florida 33484, United States

Eileen Messing, Psy D., Delray Beach, Florida 33446, United States

Florida Medical Center and Research, Inc., Miami, Florida 33142, United States

Harmony Clinical Research, Incorporated, North Miami Beach, Florida 33162, United States

Rheumatology Associates of Central Florida, PA, Orlando, Florida 32806, United States

Medical Research & Health Education Foundation, Inc., Columbus, Georgia 31909, United States

North Georgia Rheumatology, PC, Lawrenceville, Georgia 30045, United States

Mallikatta Neuro Centre, Mangalore, Karnataka 575002, India

Kosair Charities Pediatric Clinical Research Unit, Louisville, Kentucky 40202, United States

Kosair Children's Hospital, Louisville, Kentucky 40202, United States

University of Louisville, Louisville, Kentucky 40202, United States

University Pediatric Rheumatology of Kentucky, LLC, Louisville, Kentucky 40202, United States

Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics, Nagpur, Maharashtra 440010, India

University of Massachusetts Memorial Medical Center Department of Pediatrics, Worcester, Massachusetts 01655, United States

A&A Pain Institute of St. Louis, St. Louis, Missouri 63141, United States

Duke University Medical Center, Durham, North Carolina 27717, United States

Duke Medicine Plaza, Raleigh, North Carolina 27609, United States

Akron Children's Hospital, Akron, Ohio 44308, United States

Akron Children's Hospital, Boardman, Ohio 44512, United States

Boardman Medical Pavilion, Boardman, Ohio 44512, United States

University of Cincinnati, Cincinnati, Ohio 45219, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

The Research Institute at Nationwide Children's Hospital, Columbus, Ohio 43205, United States

St. Christopher's Hospital for Children / Section of Rheumatology, Philadelphia, Pennsylvania 19134-1095, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Medical University of South Carolina, Pediatric Rheumatology, Charleston, South Carolina 29425, United States

MUSC University Children's Hospital, Charleston, South Carolina 29425, United States

Carolina Research Center, Myrtle Beach, South Carolina 29572, United States

Fatigue Consultation Clinic, Salt Lake City, Utah 84102, United States

Department of Physical Medicine & Rehabilitation, Lucknow, Uttar Pradesh 226 018, India

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2010
Last updated: June 22, 2015

Page last updated: August 23, 2015

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