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Protocol Summary for ROP109087

Protocol Summary
Protocol Id: ROP109087
Secondary Ids:
  • n/a
Title: An open label, repeat dose, dose escalation study conducted in Parkinson's Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.
Phase: phase 2
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 PD 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 three 4mg ropinirole tablets versus one 12mg tablet.
Detailed Description:
Record Verification Date: February 2011
Status: Completed
Why Study Stopped:
Study Start Date: April 2007
Study Completion Date: August 2007
Study Completion Date Type: Actual
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/dynamics Study
Primary Outcomes:
  • Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours 24 hours
Secondary Outcomes:
  • Time to attain the maximum plasma concentration Incidence of adverse events over 37 days As above, but for ropinirole metabolites over 37 days
  • Vital signs, ECG and clinical laboratory data over 37 days over 37 days
Conditions:
  • Parkinson Disease
Keywords:
  • SK&F101468,
  • ropinirole PR/CR,
  • formulation,
  • pharmacokinetic,
  • food effect,
  • PD
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 30 Year
Maximum Age: 85 Year
Enrollment: 28
Enrollment Type: Actual
Healthy Volunteers?: none
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