Adolescent Fibromyalgia Study

Fibromyalgia Clinical Trial

Official title:

A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020474
• Other study ID #: A0081180
• Secondary ID: 2010-019521-34
• Status: Completed
• Phase: Phase 4
• Start date: May 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• placebo
matching placebo capsules twice daily.
• pregabalin (Lyrica)
75-450mg/day pregabalin dose optimised at start of study

Locations

Country	Name	City	State
Czechia	Bioregeneracni a rehabilitacni centrum	Ricany
India	Department of Physical Medicine & Rehabilitation	Lucknow	Uttar Pradesh
India	Mallikatta Neuro Centre	Mangalore	Karnataka
India	Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics	Nagpur	Maharashtra
India	Krishna Institute of Medical Sciences Ltd	Secunderabad	Andhra Pradesh
Taiwan	National Taiwan University Hospital	Taipei
United States	Akron Children's Hospital	Akron	Ohio
United States	Akron Children's Hospital	Boardman	Ohio
United States	Boardman Medical Pavilion	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	MUSC University Children's Hospital	Charleston	South Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	Medical Research & Health Education Foundation, Inc.	Columbus	Georgia
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Research Institute at Nationwide Children's Hospital	Columbus	Ohio
United States	Arthritis Associates of South Florida	Delray Beach	Florida
United States	Delray Research Associates	Delray Beach	Florida
United States	Eileen Messing, Psy D.	Delray Beach	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	North Georgia Rheumatology, PC	Lawrenceville	Georgia
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	Kosair Charities Pediatric Clinical Research Unit	Louisville	Kentucky
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	University Pediatric Rheumatology of Kentucky, LLC	Louisville	Kentucky
United States	Florida Medical Center and Research, Inc.	Miami	Florida
United States	Carolina Research Center	Myrtle Beach	South Carolina
United States	Harmony Clinical Research, Incorporated	North Miami Beach	Florida
United States	Rheumatology Associates of Central Florida, PA	Orlando	Florida
United States	St. Christopher's Hospital for Children / Section of Rheumatology	Philadelphia	Pennsylvania
United States	Duke Medicine Plaza	Raleigh	North Carolina
United States	A&A Pain Institute of St. Louis	Saint Louis	Missouri
United States	Fatigue Consultation Clinic	Salt Lake City	Utah
United States	Apex Research Institute	Santa Ana	California
United States	University of Massachusetts Memorial Medical Center Department of Pediatrics	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Czechia,  India,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	Week 15
Secondary	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".	Week 15
Secondary	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).	Baseline to Week 15
Secondary	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".	Baseline to Week 15
Secondary	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.	Week 15
Secondary	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).	Week 15
Secondary	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).	Week 15
Secondary	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).	Week 15

External Links

•   To obtain contact information for a study center near you, click here.