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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 21, 2017
Last verified: March 2017

May 26, 2006
March 21, 2017
June 2006
August 2007   (Final data collection date for primary outcome measure)
Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 LOCF [ Time Frame: Week 24 ]
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
  • Mean change from baseline in percentage awake time spent "off" at Week 24 LOCF [ Time Frame: Week 24 ]
  • Number of participants with a score of 'much improved' or 'very much improved' on the Clinical Global Impression-global improvement (CGI-I) scale at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total motor score of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total motor score of the UPDRS, with subjects in an "off" state.at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total ADL score of the UPDRS, with participants in an "on" state.at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total ADL score of the UPDRS, with subjects in an "off" state.at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total score of the UPDRS, with subjects in an "on" state.at Week 24 LOCF [ Time Frame: Baseline and Week 24 ]
  • Mean change from baseline in the total score of the UPDRS, with subjects in an "off" state.at Week 24 LOCF [ Time Frame: Baseline and Week 24 ]
  • Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D) [ Time Frame: baseline and Week 24 ]
  • Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D. [ Time Frame: baseline and Week 24 ]
  • Mean change from baseline in the total score of the Parkinson's Disease Sleep Scale (PDSS) at Week 24 LOCF [ Time Frame: Baseline and Week 24 ]
  • Mean change from baseline in the total movement severity score of the Abnormal Involuntary Movement Scale (AIMS), with subjects in an "on" state at Week 24 LOCF [ Time Frame: baseline and Week 24 ]
  • Percentage of participants requiring reinstatement of L-dopa. [ Time Frame: Week 24 ]
  • Mean change from baseline in the dose of L-dopa at Week 24 [ Time Frame: baseline and Week 24 ]
  • 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
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Ropinirole prolonged release
  • Drug: ropinirole immediate release
    Other Name: Ropinirole prolonged 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.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Ukraine,   United Kingdom
 
 
NCT00331149
ROP105323
No
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2017

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