A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363857
First received: August 11, 2006
Last updated: June 21, 2012
Last verified: June 2012
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | August 11, 2006 | ||||
Last Updated Date | June 21, 2012 | ||||
Start Date ICMJE | August 2003 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Improvement in RLS severity rating scale at Week 12 | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00363857 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12. | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome | ||||
Official Title ICMJE | A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS) | ||||
Brief Summary | A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States. |
||||
Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Drug: Ropinirole
Other Name: Ropinirole |
||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 360 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
Other inclusion or exclusion criteria to be evaluated by the physician. |
||||
Gender | Both | ||||
Ages | 18 Years to 79 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00363857 | ||||
Other Study ID Numbers ICMJE | 101468/249 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | GlaxoSmithKline | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |