Adolescent Fibromyalgia Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020474
First received: November 23, 2009
Last updated: September 8, 2014
Last verified: September 2014
  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: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline to week 15 in mean sleep quality diary score [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Pain Numeric Rating Scale (Pain-NRS) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • weekly change from baseline in mean pain score at weeks 1-15 [ Time Frame: weeks 1-15 ] [ Designated as safety issue: No ]
  • weekly change from baseline in mean sleep quality score at week 1-15 [ Time Frame: weeks 1-15 ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: May 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
Other Name: pregabalin (Lyrica)

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
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
Pfizer Investigational Site
Los Angeles, California, United States, 90027
Pfizer Investigational Site
Santa Ana, California, United States, 92705
United States, Florida
Pfizer Investigational Site
Coral Gables, Florida, United States, 33134
Pfizer Investigational Site
Delray Beach, Florida, United States, 33446
Pfizer Investigational Site
Delray Beach, Florida, United States, 33484
Pfizer Investigational Site
North Miami Beach, Florida, United States, 33162
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Pfizer Investigational Site
Columbus, Georgia, United States, 31909
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30045
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27717
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44308
Pfizer Investigational Site
Boardman, Ohio, United States, 44512
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19134-1095
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
Czech Republic
Pfizer Investigational Site
Ricany, Czech Republic, 25101
India
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, India, 500 003
Pfizer Investigational Site
Mangalore, Karnataka, India, 575002
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440010
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226 018
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01020474     History of Changes
Other Study ID Numbers: A0081180
Study First Received: November 23, 2009
Last Updated: September 8, 2014
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014