Protocol Summary for 108862
| Protocol Id: | 108862 |
| Secondary Ids: |
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| 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 |
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| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
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| 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 |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion criteria:
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| 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: | |
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| 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: |
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Click to view inclusion/exclusion criteria