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RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314860
First Posted: April 17, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
April 13, 2006
April 17, 2006
October 12, 2017
February 2006
December 2006   (Final data collection date for primary outcome measure)
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.
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Restless Legs Syndrome
  • Restless Legs Syndrome (RLS)
Drug: ropinirole Extended Release (XR)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
568
December 2006
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Denmark,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Argentina
 
NCT00314860
101468/204
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

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