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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for ROR106470

Protocol Summary for ROR106470

Protocol Summary
Protocol Id: ROR106470
Secondary Ids:
Title: An open label, repeat dose, dose escalation study conducted in RLS patients to characterize pharmacokinetics and food effect of ropinirole controlled release for RLS
Phase: Phase 1
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: interventional
Oversight Authority:
  • Germany: Federal Institute for Drugs and Medical Devices
  • South Africa: Medicines Control Council
Collaborators:
Brief Summary: This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: August 2006
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Open Label
Masked Subject: false
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): Pharmacokinetics Study
Primary Outcomes:
  • Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration dosing interval
Secondary Outcomes:
  • Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites Time taken for ropinirole concentration to fall to half initial value
Conditions:
  • Restless Legs Syndrome
Keywords:
  • SK&F101468,
  • controlled release for RLS,
  • formulation,
  • pharmacokinetic,
  • food effect,
  • RLS
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 65 Years
Enrollment: 32
Enrollment Type: Actual
Healthy Volunteers?: No
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information