GSK: Protocol Summary for ROP105323

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Protocol Summary for ROP105323

Protocol Summary
Protocol Id:	ROP105323
Secondary Ids:
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.
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	United Kingdom: Medicines and Healthcare products Regulatory Agency
Collaborators:
Brief Summary:	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
Detailed Description:
Record Verification Date:	November 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	June 2006
Study Completion Date:	August 2007
Study Completion Date Type:	Actual
Primary Completion Date:	August 2007
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Diary information to compare the amount of time "off"(time "off" includes a lack of mobility with or without additional features such as tremor or rigidity)the patient experiences at the start and end of the study. 24 Weeks
Secondary Outcomes:	Compare the score on Parkinson's disease and quality of life scales at the start and end of the study. Assess change in L-dopa dose. Incidence of adverse events. 24 Weeks
Conditions:	Parkinson Disease
Keywords:	safety efficacy L-dopa ropinirole PR Parkinson's disease ropinirole IR adjunctive therapy superiority REQUIP health outcomes
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion criteria: •Patients with a diagnosis of advanced idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa. Exclusion criteria: •Patients with late stage advanced Parkinson’s disease with incapacitating dyskinesias on a stable dose of L-dopa. •Current, or history of, (within the previous 3 months), significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy. •Recent history of severe dizziness or fainting on standing. •Dementia, neurotic behaviour, crippling degenerative arthritis or limb amputations, or prior or current major psychosis. •Recent history or current evidence of drug abuse or alcoholism. •Use of a dopamine agonist within 4 weeks of starting the study. •Personal or family history of an allergic reaction to ropinirole.
Gender:	Both
Minimum Age:	30 Year
Maximum Age:
Enrollment:	344
Enrollment Type:	Anticipated
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
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 Bulgaria (click to view all sites in Bulgaria) GSK Investigational Site Sofia, 1113; RECRUITING; GSK Investigational Site Sofia, 1527; RECRUITING; GSK Investigational Site Varna, 9010; RECRUITING; Canada (click to view all sites in Canada) GSK Investigational Site Halifax, Nova Scotia, B3J 3T1; COMPLETED; Czech Republic (click to view all sites in Czech Republic) GSK Investigational Site Praha 2, 120 00; COMPLETED; France (click to view all sites in France) GSK Investigational Site Clermont Ferrand, 63003; COMPLETED; GSK Investigational Site Marseille, 13385; COMPLETED; GSK Investigational Site Aix en Provence, 13616; COMPLETED; GSK Investigational Site Dijon, 21000; COMPLETED; GSK Investigational Site Lille Cedex, 59037; COMPLETED; Hungary (click to view all sites in Hungary) GSK Investigational Site Szeged, 6725; COMPLETED; Poland (click to view all sites in Poland) GSK Investigational Site Krakow, 31-530; COMPLETED; GSK Investigational Site Gdansk, 80-299; COMPLETED; GSK Investigational Site Katowice, 40-752; COMPLETED; GSK Investigational Site Warsaw, 02-097; COMPLETED; Romania (click to view all sites in Romania) GSK Investigational Site Bucharest, 11241; COMPLETED; Spain (click to view all sites in Spain) GSK Investigational Site San Sebastian, 20011; COMPLETED; United Kingdom (click to view all sites in United Kingdom) GSK Investigational Site Chertsey, KT16 0QA; COMPLETED; GSK Investigational Site Stoke-on-Trent, Staffordshire, ST4 7PA; COMPLETED;

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Protocol Summary for ROP105323