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NCT01020526 Clinical Trial

Pregabalin In Adolescent Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01020526
Other study ID # A0081231
Secondary ID 2010-020300-29
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2010
Est. completion date June 2015

Study information
Verified date May 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions. Exclusion Criteria: - 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

Related Conditions & MeSH terms

Intervention

Drug:
• pregabalin
Oral capsule 75-450 mg/day

Locations
Country Name City State
Czechia Bioregeneracni a rehabilitacni centrum Ricany
India King George's Medical University Lucknow Uttar Pradesh
India Mallikatta Neuro Center Mangalore Karnataka
India Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics Nagpur Maharashtra
India Krishna Institute of Medical Sciences Ltd Secunderabad Andhra Pradesh
United States Akron Children's Hospital Akron Ohio
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 University of Cincinnati Department of Psychiatry and Behavioral Neuroscience 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 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 & Research 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 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, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Pain Numeric Rating Scale by Week 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. Baseline, Weeks 3, 8, 16, 24 and Last Visit.
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