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Protocol Summary for 108862

Protocol Summary
Protocol Id: 108862
Secondary Ids:
  • N/A
Title: Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients with Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
Phase: phase 4
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Japan: Ministry of Health, Labour and Welfare
Collaborators:
Brief Summary: Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006. ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at >10mg/day is limited. For this reason, this study was designed as a multicenter open-label uncontrolled study. This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn & Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.
Detailed Description:
Record Verification Date: November 2010
Status: Completed
Why Study Stopped:
Study Start Date: June 2007
Study Completion Date: December 2009
Study Completion Date Type: Actual
Primary Completion Date: December 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Non-randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Efficacy<Adjunct Therapy Group (REQUIP+L-dopa)>- Change from baseline in Japanese UPDRS Part III total score (recorded in an every 4 weeks for 52 weeks
Secondary Outcomes:
  • Safety- Adverse events: type, severity and frequency- Clinical laboratory tests (hematology, clinical chemistry)- ECG (standard 12-lead ECG)- Vital signs (blood pressure, pulse rate) For 52 weeks
Conditions:
  • Parkinson Disease
Keywords:
  • Ropinirole hydrochloride
  • L-dopa
  • Parkinson's Disease
  • Dopamine agonist
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 20 Year
Maximum Age:
Enrollment: 123
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email:
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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