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Adolescent Fibromyalgia Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020474
First received: November 23, 2009
Last updated: June 22, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention Phase
Fibromyalgia
Drug: placebo
Drug: pregabalin (Lyrica)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to Week 15 in Mean Pain Diary Score [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").


Secondary Outcome Measures:
  • Change From Baseline to Week 15 in Mean Sleep Quality Diary Score [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".

  • Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline to Week 15 ] [ Designated as safety issue: No ]
    Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

  • Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) [ Time Frame: Baseline to Week 15 ] [ Designated as safety issue: No ]
    Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".

  • Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    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 greater degree of impairment. Participants choose the number that best describes the pain during the last week.

  • Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

  • Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

  • Proportion of Patient Global Impression Change (PGIC) at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).


Enrollment: 107
Study Start Date: May 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
matching placebo capsules twice daily.
Experimental: drug-pregabalin Drug: pregabalin (Lyrica)
75-450mg/day pregabalin dose optimised at start of study

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01020474

  Hide Study Locations
Locations
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
Eileen Messing, Psy D.
Delray Beach, Florida, United States, 33446
Arthritis Associates of South Florida
Delray Beach, Florida, United States, 33484
Delray Research Associates
Delray Beach, Florida, United States, 33484
Florida Medical Center and Research, Inc.
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
North Georgia Rheumatology, PC
Lawrenceville, Georgia, United States, 30045
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, Missouri
A&A Pain Institute of St. Louis
St. Louis, Missouri, United States, 63141
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27717
Duke Medicine Plaza
Raleigh, North Carolina, United States, 27609
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Akron Children's Hospital
Boardman, Ohio, United States, 44512
Boardman Medical Pavilion
Boardman, Ohio, United States, 44512
University of Cincinnati
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, Pennsylvania
St. Christopher's Hospital for Children / Section of Rheumatology
Philadelphia, Pennsylvania, United States, 19134-1095
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
MUSC University Children's Hospital
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
India
Krishna Institute of Medical Sciences Ltd
Secunderabad, Andhra Pradesh, India, 500 003
Mallikatta Neuro Centre
Mangalore, Karnataka, India, 575002
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Nagpur, Maharashtra, India, 440010
Department of Physical Medicine & Rehabilitation
Lucknow, Uttar Pradesh, India, 226 018
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01020474     History of Changes
Other Study ID Numbers: A0081180  2010-019521-34 
Study First Received: November 23, 2009
Results First Received: May 26, 2015
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
juvenile primary fibromyalgia syndrome
pediatric fibromyalgia
pregabalin
and Lyrica

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2016