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Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00256854
First received: November 21, 2005
Last updated: September 22, 2016
Last verified: September 2016

November 21, 2005
September 22, 2016
November 2005
September 2006   (final data collection date for primary outcome measure)
adverse events (AE) post-conversion from ropinirole IR to ropinirole controlled-release for RLS [ Designated as safety issue: No ]
adverse events (AE) post-conversion from ropinirole IR to ropinirole controlled-release for RLS
Complete list of historical versions of study NCT00256854 on ClinicalTrials.gov Archive Site
Proportion discontinuing drug due to AEs after conversion from ropinirole IR to ropinirole controlled-release for RLS, analyses of AEs and vital signs, efficacy parameters(International RLS (IRLS) Rating Scale) [ Designated as safety issue: No ]
Proportion discontinuing drug due to AEs after conversion from ropinirole IR to ropinirole controlled-release for RLS, analyses of AEs and vital signs, efficacy parameters (International RLS Rating Scale
Not Provided
Not Provided
 
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients With Restless Legs Syndrome (RLS)
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Restless Legs Syndrome
  • Restless Legs Syndrome (RLS)
Drug: ropinirole controlled-release for RLS
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
135
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
  • Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
  • Subjects with RLS symptoms during both the evening and night or night time only.
  • Subjects who have given written informed consent to participate.

Exclusion Criteria:

  • Subjects who require treatment of daytime RLS symptoms.
  • Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
  • Movement Disorders, Clinically significant or unstable medical conditions.
  • Abnormal labs, electrocardiogram (ECG) or physical findings.
  • Receiving prohibited medications.
  • Sleeping habits incompatible with study design.
  • Intolerance to ropinirole or other dopamine agonist.
  • Pregnant or lactating.
  • Women of child-bearing potential who are not practicing an acceptable method of birth control.
Both
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00256854
ROX104805
Not Provided
Yes
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
September 2016

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