Pregabalin In Adolescent Patients With Fibromyalgia

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ricany, Czechia, 25101
        • Bioregeneracni a rehabilitacni centrum
  • India
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, India, 500 003
        • Krishna Institute of medical sciences Ltd
    • Karnataka
      • Mangalore, Karnataka, India, 575002
        • Mallikatta Neuro Center
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 018
        • King George's Medical University
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Childrens Hospital Los Angeles
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
    • Florida
      • Miami, Florida, United States, 33142
        • Florida Medical Center & Research
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research, Incorporated
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida, PA
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Medical Research & Health Education Foundation, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40202
        • Kosair Children's Hospital
      • Louisville, Kentucky, United States, 40202
        • Kosair Charities Pediatric Clinical Research Unit
      • Louisville, Kentucky, United States, 40202
        • University Pediatric Rheumatology of Kentucky, LLC
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center Department of Pediatrics
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital
      • Boardman, Ohio, United States, 44512
        • Akron Children's Hospital-Mahoning Valley
      • Boardman, Ohio, United States, 44512
        • Akron Children's Hospital
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
      • Columbus, Ohio, United States, 43205
        • The Research Institute at Nationwide Children's Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina, Pediatric Rheumatology
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Fatigue Consultation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin
Drug: pregabalin
Oral capsule 75-450 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain Numeric Rating Scale by Week
Time Frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081231
  • 2010-020300-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on pregabalin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe