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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00331149 |
This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Ropinirole prolonged release Drug: ropinirole immediate release |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-Dopa. |
Estimated Enrollment: | 344 |
Study Start Date: | June 2006 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ROP105323 |
Study First Received: | May 26, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00331149 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Parkinson's disease REQUIP ropinirole PR ropinirole IR L-dopa |
adjunctive therapy safety efficacy superiority health outcomes |
Levodopa Ropinirole Dopamine Ganglion Cysts Movement Disorders Parkinson Disease |
Basal Ganglia Diseases Dihydroxyphenylalanine Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Antiparkinson Agents Dopamine Agents Dopamine Agonists Central Nervous System Agents Pharmacologic Actions |