Pregabalin In Adolescent Patients With Fibromyalgia
- Registration Number
- NCT01020526
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregabalin pregabalin -
- Primary Outcome Measures
Name Time Method Change From Baseline in Pain Numeric Rating Scale by Week 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
🇮🇳Nagpur, Maharashtra, India
University of Louisville
🇺🇸Louisville, Kentucky, United States
Krishna Institute of Medical Sciences Ltd
🇮🇳Secunderabad, Andhra Pradesh, India
Mallikatta Neuro Center
🇮🇳Mangalore, Karnataka, India
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Rheumatology Associates of Central Florida, PA
🇺🇸Orlando, Florida, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Massachusetts Memorial Medical Center Department of Pediatrics
🇺🇸Worcester, Massachusetts, United States
The Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Bioregeneracni a rehabilitacni centrum
🇨🇿Ricany, Czechia
King George's Medical University
🇮🇳Lucknow, Uttar Pradesh, India
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
🇺🇸Cincinnati, Ohio, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Florida Medical Center & Research
🇺🇸Miami, Florida, United States
Medical Research & Health Education Foundation, Inc.
🇺🇸Columbus, Georgia, United States
Harmony Clinical Research, Incorporated
🇺🇸North Miami Beach, Florida, United States
Kosair Charities Pediatric Clinical Research Unit
🇺🇸Louisville, Kentucky, United States
University Pediatric Rheumatology of Kentucky, LLC
🇺🇸Louisville, Kentucky, United States
Akron Children's Hospital
🇺🇸Boardman, Ohio, United States
Akron Children's Hospital-Mahoning Valley
🇺🇸Boardman, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina, Pediatric Rheumatology
🇺🇸Charleston, South Carolina, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Carolina Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Fatigue Consultation Clinic
🇺🇸Salt Lake City, Utah, United States