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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00331149

Purpose

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
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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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)

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331149

Show 72 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ROP105323
Study First Received:	May 26, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00331149 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Parkinson's disease
REQUIP
ropinirole PR
ropinirole IR
L-dopa

adjunctive therapy
safety
efficacy
superiority
health outcomes

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 09, 2009