Protocol Summary for ROP109087
| Protocol Id: | ROP109087 |
| Secondary Ids: |
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| 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 |
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| 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 |
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| 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: |
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| Keywords: |
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| Eligibility Criteria: |
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Inclusion 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: |
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information
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Click to view inclusion/exclusion criteria