Adolescent Fibromyalgia Study
- Registration Number
- NCT01020474
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- Diagnosis of fibromyalgia
- 12-17 years of age
- Patients with other pain conditions
- Previous treatment with pregabalin
- Patients taking excluded medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description drug-pregabalin pregabalin (Lyrica) - Placebo placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 15 in Mean Pain Diary Score Week 15 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
Name Time Method Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) Baseline to Week 15 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 Sleep Quality Diary Score Week 15 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) Baseline to Week 15 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).
Proportion of Patient Global Impression Change (PGIC) at Week 15 Week 15 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).
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) Week 15 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 Week 15 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 Week 15 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).
Trial Locations
- Locations (35)
Harmony Clinical Research, Incorporated
🇺🇸North Miami Beach, Florida, United States
A&A Pain Institute of St. Louis
🇺🇸Saint Louis, Missouri, United States
Arthritis Associates of South Florida
🇺🇸Delray Beach, Florida, United States
North Georgia Rheumatology, PC
🇺🇸Lawrenceville, Georgia, United States
Kosair Charities Pediatric Clinical Research Unit
🇺🇸Louisville, Kentucky, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Florida Medical Center and Research, Inc.
🇺🇸Miami, Florida, United States
Medical Research & Health Education Foundation, Inc.
🇺🇸Columbus, Georgia, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Eileen Messing, Psy D.
🇺🇸Delray Beach, Florida, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Delray Research Associates
🇺🇸Delray Beach, Florida, United States
Rheumatology Associates of Central Florida, PA
🇺🇸Orlando, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University Pediatric Rheumatology of Kentucky, LLC
🇺🇸Louisville, Kentucky, United States
University of Massachusetts Memorial Medical Center Department of Pediatrics
🇺🇸Worcester, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Duke Medicine Plaza
🇺🇸Raleigh, North Carolina, United States
Akron Children's Hospital
🇺🇸Boardman, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
The Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
St. Christopher's Hospital for Children / Section of Rheumatology
🇺🇸Philadelphia, Pennsylvania, United States
MUSC University Children's Hospital
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina, Pediatric Rheumatology
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Carolina Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Fatigue Consultation Clinic
🇺🇸Salt Lake City, Utah, United States
Bioregeneracni a rehabilitacni centrum
🇨🇿Ricany, Czechia
Krishna Institute of Medical Sciences Ltd
🇮🇳Secunderabad, Andhra Pradesh, India
Mallikatta Neuro Centre
🇮🇳Mangalore, Karnataka, India
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
🇮🇳Nagpur, Maharashtra, India
Department of Physical Medicine & Rehabilitation
🇮🇳Lucknow, Uttar Pradesh, India
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Boardman Medical Pavilion
🇺🇸Boardman, Ohio, United States