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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00434304 |
Purpose
This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Ropinirole prolonged release/extended release(PR/XR) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - <Clinical Pharmacology / Exploratory Study> |
| Enrollment: | 62 |
| Study Start Date: | April 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Ropinirole PR/XR: Experimental |
Drug: Ropinirole prolonged release/extended release(PR/XR)
Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2mg/day, and increased to 8mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16.0 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The seriousness refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).
Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week-4 to Week0.
Contacts and Locations| Japan | |
| GSK Investigational Site | |
| Aichi, Japan, 455-0018 | |
| GSK Investigational Site | |
| Chiba, Japan, 279-0021 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 070-0901 | |
| GSK Investigational Site | |
| Kyoto, Japan, 600-8811 | |
| GSK Investigational Site | |
| Aichi, Japan, 460-0008 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 251-0038 | |
| GSK Investigational Site | |
| Tokyo, Japan, 113-0033 | |
| GSK Investigational Site | |
| Osaka, Japan, 570-8507 | |
| GSK Investigational Site | |
| Iwate, Japan, 020-0878 | |
| GSK Investigational Site | |
| Ehime, Japan, 791-0204 | |
| GSK Investigational Site | |
| Tokyo, Japan, 136-0075 | |
| GSK Investigational Site | |
| Saitama, Japan, 343-0032 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | ROP106064 |
| Study First Received: | February 9, 2007 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00434304 History of Changes |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency; Japan: Ministry of Health, Labor and Welfare |
|
PD Parkinson's Disease |
|
Neurotransmitter Agents Ropinirole Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Dopamine Agonists |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |