Fibromyalgia Study In Adults

September 13, 2016 updated by: GlaxoSmithKline

A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia

A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

164

Phase

  • Phase 2

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

  • Belgium
      • Bruxelles, Belgium, 1070
        • GSK Investigational Site
      • Diepenbeek, Belgium, 3590
        • GSK Investigational Site
      • Merksem, Belgium, 2170
        • GSK Investigational Site
  • Denmark
      • Frederiksberg, Denmark, 2000
        • GSK Investigational Site
  • Finland
      • Jyvaskyla, Finland, 40100
        • GSK Investigational Site
      • Kuopio, Finland, 70100
        • GSK Investigational Site
      • Mikkeli, Finland, 50100
        • GSK Investigational Site
  • France
      • Lomme, France, 59160
        • GSK Investigational Site
      • Paris, France, 75012
        • GSK Investigational Site
      • Paris, France, 75006
        • GSK Investigational Site
  • Germany
    • Baden-Wuerttemberg
      • Fellbach, Baden-Wuerttemberg, Germany, 70736
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • GSK Investigational Site
    • Hessen
      • Bad Hersfeld, Hessen, Germany, 36251
        • GSK Investigational Site
      • Huettenberg, Hessen, Germany, 35625
        • GSK Investigational Site
  • Italy
    • Campania
      • Benevento, Campania, Italy, 82100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00161
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
  • Netherlands
      • Zwolle, Netherlands, 8011 JW
        • GSK Investigational Site
  • Sweden
      • Mölndal, Sweden, SE-431 37
        • GSK Investigational Site
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • GSK Investigational Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • GSK Investigational Site
    • Dorset
      • Poole, Dorset, United Kingdom, BH15 2JB
        • GSK Investigational Site

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of primary fibromyalgia as defined by the American College of Rheumatology (ACR).
  • Females of childbearing potential will only be eligible if taking adequate contraceptive measures.
  • Other co-existent chronic pain conditions such as osteoarthritis, will not exclude the subject if the pain associated with the condition is less severe than the pain of fibromyalgia.
  • Only subjects experiencing moderate/severe pain (pain intensity score >= 4 on the pain numerical rating scale) will be eligible for this study.
  • Subjects that are generally well.
  • Have the ability to discontinue prohibited medications for the duration of the study.

Exclusion criteria:

  • Subjects with 'flare' of arthritic conditions.
  • Evidence of clinically significant medical conditions including cardiovascular conditions (e.g. postural hypotension, and raised blood pressure, ECG abnormalities).
  • History of drug and/or alcohol abuse or major depression.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in pain intensity score from baseline to last week of treatment (week 12)

Secondary Outcome Measures

Outcome Measure
Pain relief. Global function: PGIC (Patient Global Impression of Change)and CGIC (Clinical Global Impression of Change), FIQ (Fibromyalgia Impact Questionnaire), Pain severity and impact on physical function, Sleep quality, tender pointpressure threshold

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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.

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

November 1, 2004

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROF102100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: ROF102100
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: ROF102100
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: ROF102100
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: ROF102100
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: ROF102100
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: ROF102100
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: ROF102100
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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.

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