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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

May 26, 2006
March 7, 2013
June 2006
August 2007   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00331149 on ClinicalTrials.gov Archive Site
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 ]
  • 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.
Not Provided
Not Provided
 
A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Parkinson Disease
  • Parkinson's Disease
  • Drug: Ropinirole prolonged release
  • Drug: ropinirole immediate release
    Other Names:
    • Ropinirole prolonged release
    • ropinirole immediate release
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
344
August 2007
August 2007   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Czech Republic,   France,   Hungary,   Poland,   Romania,   Spain,   United Kingdom
 
NCT00331149
ROP105323
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2012

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