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Pregabalin In Adolescent Patients With Fibromyalgia

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 23, 2009
Last updated: May 24, 2016
Last verified: May 2016
The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin

Condition Intervention Phase
Fibromyalgia Drug: pregabalin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Pain Numeric Rating Scale by Week [ Time Frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit. ]
    The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.

Enrollment: 63
Study Start Date: September 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Drug: pregabalin
Oral capsule 75-450 mg/day


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

  • Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01020526

United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Apex Research Institute
Santa Ana, California, United States, 92705
United States, Florida
Florida Medical Center & Research
Miami, Florida, United States, 33142
Harmony Clinical Research, Incorporated
North Miami Beach, Florida, United States, 33162
Rheumatology Associates of Central Florida, PA
Orlando, Florida, United States, 32806
United States, Georgia
Medical Research & Health Education Foundation, Inc.
Columbus, Georgia, United States, 31909
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
University of Louisville
Louisville, Kentucky, United States, 40202
University Pediatric Rheumatology of Kentucky, LLC
Louisville, Kentucky, United States, 40202
United States, Massachusetts
University of Massachusetts Memorial Medical Center Department of Pediatrics
Worcester, Massachusetts, United States, 01655
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Akron Children's Hospital-Mahoning Valley
Boardman, Ohio, United States, 44512
Akron Children's Hospital
Boardman, Ohio, United States, 44512
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, South Carolina
Medical University of South Carolina, Pediatric Rheumatology
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Carolina Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Utah
Fatigue Consultation Clinic
Salt Lake City, Utah, United States, 84102
Czech Republic
Bioregeneracni a rehabilitacni centrum
Ricany, Czech Republic, 25101
Krishna Institute of Medical Sciences Ltd
Secunderabad, Andhra Pradesh, India, 500 003
Mallikatta Neuro Center
Mangalore, Karnataka, India, 575002
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Nagpur, Maharashtra, India, 440010
King George's Medical University
Lucknow, Uttar Pradesh, India, 226 018
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT01020526     History of Changes
Other Study ID Numbers: A0081231
2010-020300-29 ( EudraCT Number )
Study First Received: November 23, 2009
Results First Received: May 24, 2016
Last Updated: May 24, 2016

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on September 25, 2017