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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00331149
First received: May 26, 2006
Last updated: March 7, 2013
Last verified: March 2012
History of Changes
  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 Disease
Parkinson's Disease
 Drug: Ropinirole prolonged release
Drug: ropinirole immediate release
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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)
Intervention Details:
    Drug: Ropinirole prolonged release Drug: ropinirole immediate release
    Other Names:
    • Ropinirole prolonged release
    • ropinirole immediate release
  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

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
Czech Republic
GSK Investigational Site
Praha 2, Czech Republic, 120 00
France
GSK Investigational Site
Aix en Provence, France, 13616
GSK Investigational Site
Clermont Ferrand, France, 63003
GSK Investigational Site
Dijon, France, 21000
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Marseille, France, 13385
Hungary
GSK Investigational Site
Szeged, Hungary, 6725
Poland
GSK Investigational Site
Gdansk, Poland, 80-299
GSK Investigational Site
Katowice, Poland, 40-752
GSK Investigational Site
Krakow, Poland, 31-530
GSK Investigational Site
Warsaw, Poland, 02-097
Romania
GSK Investigational Site
Bucharest, Romania, 11241
Spain
GSK Investigational Site
San Sebastian, Spain, 20011
United Kingdom
GSK Investigational Site
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 7PA
GSK Investigational Site
Chertsey, United Kingdom, KT16 0QA
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00331149     History of Changes
Other Study ID Numbers: ROP105323
Study First Received: May 26, 2006
Last Updated: March 7, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
safety
efficacy
L-dopa
ropinirole PR
Parkinson's disease
 ropinirole IR
adjunctive therapy
superiority
REQUIP
health outcomes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Antiparkinson Agents
 Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013