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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
matching placebo capsules twice daily.
75-450mg/day pregabalin dose optimised at start of study
Change From Baseline to Week 15 in Mean Pain Diary Score
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").
Time frame: Week 15
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
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".
Time frame: Week 15
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
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).
Time frame: Baseline to Week 15
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
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".
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Childrens Hospital Los Angeles
Los Angeles, California, United States
Apex Research Institute
Santa Ana, California, United States
Eileen Messing, Psy D.
Delray Beach, Florida, United States
Arthritis Associates of South Florida
Delray Beach, Florida, United States
Delray Research Associates
Delray Beach, Florida, United States
Florida Medical Center and Research, Inc.
Miami, Florida, United States
Harmony Clinical Research, Incorporated
North Miami Beach, Florida, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, United States
Medical Research & Health Education Foundation, Inc.
Columbus, Georgia, United States
North Georgia Rheumatology, PC
Lawrenceville, Georgia, United States
...and 26 more locations
Time frame: Baseline to Week 15
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
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.
Time frame: Week 15
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at 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).
Time frame: Week 15
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at 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).
Time frame: Week 15
Proportion of Patient Global Impression Change (PGIC) at 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).
Time frame: Week 15