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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for RRL103628

Protocol Summary for RRL103628

Protocol Summary
Protocol Id: RRL103628
Secondary Ids:
Title: An Open-Label, Parallel-Group, Repeat-Dose Study to Investigate the Effects of End Stage Renal Disease and Haemodialysis on the Pharmacokinetics of Ropinirole (Study RRL103628)
Phase: Phase 1
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 70,140
IND/IDE Serial Number: 0038
Has Expanded Access?:
Study Type: interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: April 2006
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Diagnostic
Allocation: Non-randomized
Masking: Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Pharmacokinetics Study
Primary Outcomes:
  • SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.
  • SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when "on dialysis" & "off dialysis" in patients.
Secondary Outcomes:
  • ECG: every other visit
  • Vital Signs: Each visit
  • Adverse Events: each visit
  • Clinical laboratory: every other visit
Conditions:
  • Restless Legs Syndrome
Keywords:
  • ropinirole
  • hemodialysis
  • end stage renal impairment
  • pharmacokinetics
  • tolerability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 79 Years
Enrollment: 48
Enrollment Type:
Healthy Volunteers?: Yes
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