Fibromyalgia Study In Adults

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 21, 2005
Last updated: April 11, 2013
Last verified: February 2011

November 21, 2005
April 11, 2013
November 2004
Not Provided
Change in pain intensity score from baseline to last week of treatment (week 12)
Same as current
Complete list of historical versions of study NCT00256893 on Archive Site
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
Same as current
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Fibromyalgia Study In Adults
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.
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Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Fibromyalgia Syndrome, Primary
Drug: ropinirole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Sweden,   United Kingdom
Belgium,   Denmark,   Finland,   France,   Germany,   Italy
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Study Director: GSK Clinical Trials GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP