Fibromyalgia Study In Adults

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00256893

Collaborator

(none)

164

Enrollment

Locations

Duration (Months)

7.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome, Primary	Drug: ropinirole	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2004

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Change in pain intensity score from baseline to last week of treatment (week 12) []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bruxelles		Belgium	1070
2	GSK Investigational Site	Diepenbeek		Belgium	3590
3	GSK Investigational Site	Merksem		Belgium	2170
4	GSK Investigational Site	Frederiksberg		Denmark	2000
5	GSK Investigational Site	Jyvaskyla		Finland	40100
6	GSK Investigational Site	Kuopio		Finland	70100
7	GSK Investigational Site	Mikkeli		Finland	50100
8	GSK Investigational Site	Lomme		France	59160
9	GSK Investigational Site	Paris		France	75006
10	GSK Investigational Site	Paris		France	75012
11	GSK Investigational Site	Fellbach	Baden-Wuerttemberg	Germany	70736
12	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg	Germany	69120
13	GSK Investigational Site	Bad Hersfeld	Hessen	Germany	36251
14	GSK Investigational Site	Huettenberg	Hessen	Germany	35625
15	GSK Investigational Site	Benevento	Campania	Italy	82100
16	GSK Investigational Site	Roma	Lazio	Italy	00161
17	GSK Investigational Site	Milano	Lombardia	Italy	20157
18	GSK Investigational Site	Zwolle		Netherlands	8011 JW
19	GSK Investigational Site	Mölndal		Sweden	SE-431 37
20	GSK Investigational Site	Cambridge	Cambridgeshire	United Kingdom	CB2 0QQ
21	GSK Investigational Site	Truro	Cornwall	United Kingdom	TR1 3LJ
22	GSK Investigational Site	Poole	Dorset	United Kingdom	BH15 2JB