Clinical trial NCT00256893: Fibromyalgia Study In Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia Syndrome, Primary
Keywords: pain intensity
numerical rating scale
fibromyalgia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain intensity score from baseline to last week of treatment (week 12)
Secondary outcomes:
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
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Diepenbeek
country: Belgium
facility: GSK Investigational Site
city: Merksem
country: Belgium
facility: GSK Investigational Site
city: Frederiksberg
country: Denmark
facility: GSK Investigational Site
city: Jyvaskyla
country: Finland
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Mikkeli
country: Finland
facility: GSK Investigational Site
city: Lomme
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Fellbach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bad Hersfeld
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Huettenberg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Benevento
country: Italy
facility: GSK Investigational Site
state: Campania
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Zwolle
country: Netherlands
facility: GSK Investigational Site
city: Mölndal
country: Sweden
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Truro
country: United Kingdom
facility: GSK Investigational Site
state: Cornwall
city: Poole
country: United Kingdom
facility: GSK Investigational Site
state: Dorset
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: