A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's - Tabular View

Tracking Information

First Received Date ^ICMJE

May 26, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

June 2006

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 24 Weeks ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00331149 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 24 Weeks ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

Official Title ^ICMJE

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.

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Ropinirole prolonged release
Drug: ropinirole immediate release

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

344

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00331149

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

ROP105323

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP