MedPath

Adolescent Fibromyalgia Study

Phase 4
Completed
Conditions
Fibromyalgia
Interventions
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
drug-pregabalinpregabalin (Lyrica)-
Placeboplacebo-
Primary Outcome Measures
NameTimeMethod
Change From Baseline to Week 15 in Mean Pain Diary ScoreWeek 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
NameTimeMethod
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 ScoreWeek 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 15Week 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 15Week 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 15Week 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)

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

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Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States

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