Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256893
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-11-21
Brief Title:
Fibromyalgia Study In Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None