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RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
This study has been completed.
Study NCT00314860   Information provided by GlaxoSmithKline
First Received: April 13, 2006   Last Updated: May 21, 2009   History of Changes

April 13, 2006
May 21, 2009
February 2006
 
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms [ Time Frame: 12 Weeks ]
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms
Complete list of historical versions of study NCT00314860 on ClinicalTrials.gov Archive Site
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS. [ Time Frame: 12 Weeks ]
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.
 
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Restless Legs Syndrome (RLS)
Drug: ropinirole Extended Release (XR)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
480
 
 

Inclusion Criteria:

  • Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
  • Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.

Exclusion criteria:

  • Signs of secondary RLS.
  • Primary sleep disorder or movement disorder other than RLS.
  • Unstable medical conditions.
  • Inability to tolerate dopamine agonists or dopamine antagonists.
  • Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Denmark,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom
 
NCT00314860
Study Director, GSK
101468/204
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

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