Pregabalin In Adolescent Patients With Fibromyalgia
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
2 other identifiers
interventional
63
3 countries
26
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2010
Longer than P75 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 1, 2016
CompletedJanuary 28, 2021
May 1, 2016
4.8 years
November 23, 2009
May 24, 2016
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Pain Numeric Rating Scale by Week
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.
Baseline, Weeks 3, 8, 16, 24 and Last Visit.
Study Arms (1)
Pregabalin
EXPERIMENTALInterventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Florida Medical Center & Research
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
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
University of Massachusetts Memorial Medical Center Department of Pediatrics
Worcester, Massachusetts, 01655, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Akron Children's Hospital-Mahoning Valley
Boardman, Ohio, 44512, United States
Akron Children's Hospital
Boardman, Ohio, 44512, United States
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
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
Medical University of South Carolina, Pediatric Rheumatology
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
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
Bioregeneracni a rehabilitacni centrum
Říčany, 25101, Czechia
Krishna Institute of Medical Sciences Ltd
Secunderabad, Andhra Pradesh, 500 003, India
Mallikatta Neuro Center
Mangalore, Karnataka, 575002, India
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Nagpur, Maharashtra, 440010, India
King George's Medical University
Lucknow, Uttar Pradesh, 226 018, India
Related Publications (1)
Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4.
PMID: 27475753DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2009
First Posted
November 25, 2009
Study Start
September 1, 2010
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
January 28, 2021
Results First Posted
July 1, 2016
Record last verified: 2016-05