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

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Locations

Bulgaria
GSK Investigational Site
Sofia, Bulgaria, 1113
GSK Investigational Site
Sofia, Bulgaria, 1527
GSK Investigational Site
Varna, Bulgaria, 9010
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3J 3T1
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1G 4G3
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
GSK Investigational Site
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
GSK Investigational Site
Québec, Quebec, Canada, G1R 3X5
Czech Republic
GSK Investigational Site
Praha 2, Czech Republic, 120 00
GSK Investigational Site
Pardubice, Czech Republic, 535 03
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
GSK Investigational Site
Praha 5, Czech Republic, 150 18
GSK Investigational Site
Brno, Czech Republic, 625 00
France
GSK Investigational Site
Aix en Provence, France, 13616
GSK Investigational Site
Marseille, France, 13385
GSK Investigational Site
Dijon, France, 21000
GSK Investigational Site
Paris Cedex 14, France, 75674
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Clermont Ferrand, France, 63003
Germany
GSK Investigational Site
Berlin, Germany, 12163
Germany, Bayern
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Nuernberg, Bayern, Germany, 90402
Germany, Niedersachsen
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
GSK Investigational Site
Westerstede, Niedersachsen, Germany, 26655
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
Germany, Nordrhein-Westfalen
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33647
Germany, Sachsen
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
Germany, Thueringen
GSK Investigational Site
Gera, Thueringen, Germany, 07551
Hungary
GSK Investigational Site
Debrecen, Hungary, 4012
GSK Investigational Site
Szeged, Hungary, 6725
GSK Investigational Site
Budapest, Hungary, 1021
Italy, Abruzzo
GSK Investigational Site
Chieti Scalo, Abruzzo, Italy, 66013
Italy, Campania
GSK Investigational Site
Napoli, Campania, Italy, 80131
Italy, Lazio
GSK Investigational Site
Roma, Lazio, Italy, 00148
GSK Investigational Site
Roma, Lazio, Italy, 00163
Italy, Liguria
GSK Investigational Site
Genova, Liguria, Italy, 16132
Italy, Lombardia
GSK Investigational Site
Milano, Lombardia, Italy, 20126
GSK Investigational Site
Milano, Lombardia, Italy, 20142
Italy, Toscana
GSK Investigational Site
Grosseto, Toscana, Italy, 58100
GSK Investigational Site
Lido di Camaiore (Lucca), Toscana, Italy, 55043
Poland
GSK Investigational Site
Warsaw, Poland, 02-097
GSK Investigational Site
Poznan, Poland, 61-298
GSK Investigational Site
Gdansk, Poland, 80-299
GSK Investigational Site
Lublin, Poland, 20-718
GSK Investigational Site
Krakow, Poland, 31-530
GSK Investigational Site
Katowice, Poland, 40-752
Romania
GSK Investigational Site
Bucharest, Romania, 11241
Russian Federation
GSK Investigational Site
St-Petersburg, Russian Federation, 194354
GSK Investigational Site
Moscow, Russian Federation, 125101
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
St.-Petersburg, Russian Federation, 194291
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
Moscow, Russian Federation, 117049
GSK Investigational Site
Moscow, Russian Federation, 117593
GSK Investigational Site
Moscow, Russian Federation, 119881
South Africa
GSK Investigational Site
SUNNINGHILL, South Africa, 2157
GSK Investigational Site
Cape Town, South Africa, 7925
South Africa, Gauteng
GSK Investigational Site
Pretoria, Gauteng, South Africa, 0040
Spain
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Sant Cugat del Valles (Barcelona), Spain, 08190
GSK Investigational Site
San Sebastian, Spain, 20011
GSK Investigational Site
Alcorcon (Madrid), Spain, 28922
Ukraine
GSK Investigational Site
Vinnitsa, Ukraine, 21018
GSK Investigational Site
Kyiv, Ukraine, 04114
GSK Investigational Site
Kyiv, Ukraine, 01021
GSK Investigational Site
Poltava, Ukraine, 36024
United Kingdom
GSK Investigational Site
Chertsey, United Kingdom, KT16 0QA
GSK Investigational Site
Oxford, United Kingdom, OX3 9DU
GSK Investigational Site
Leigh, United Kingdom, WN7 1HS
United Kingdom, Gloucestershire
GSK Investigational Site
Bristol, Gloucestershire, United Kingdom, BS16 1LE
United Kingdom, Staffordshire
GSK Investigational Site
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 7PA

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 27, 2009