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Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
This study has been completed.
Study NCT00434304   Information provided by GlaxoSmithKline
First Received: February 9, 2007   Last Updated: October 8, 2009   History of Changes

February 9, 2007
October 8, 2009
April 2007
March 2009   (final data collection date for primary outcome measure)
AUC, Cmax and tmax in the fed and fasted state up to 24-hour post dose in the Maintenance phase and through concentration (Cmin) and in the fixed titration phase at 24-hour post dose of the last dose of 2, 4, and 8mg dose administration [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
AUC, Cmax and tmax in the fed and fasted state up to 24-hour post dose in the Maintenance phase and through concentration (Cmin) and in the fixed titration phase at 24-hour post dose of the last dose of 2, 4, and 8mg dose administration
Complete list of historical versions of study NCT00434304 on ClinicalTrials.gov Archive Site
  • Japanese UPDRS(PartⅠ,Ⅱ,Ⅲ and Ⅳ) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
  • Modified Hoehn & Yahr criteria stages [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who continuously participated in the study [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
  • Clinician's global impression on efficacy [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
  • Laboratory tests (haematology, biochemistry and urine) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
  • Electrocardiography (Standard 12-Lead ECG) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
  • Vital signs (blood pressure, pulse rate) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
Adverse events and Change from baseline in the Japanese UPDRS motor score in Part III (motor scores) at Week 16
 
Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - <Clinical Pharmacology / Exploratory Study>

This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.

 
Phase II
Interventional
Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
Parkinson's Disease
Drug: Ropinirole prolonged release/extended release(PR/XR)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
62
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are diagnosed with PD with severity of the Modified Hoehn & Yahr staging at Stage I to III.
  • Age: 20 years or older (at the time of giving informed consent)
  • Gender: male and female
  • Both inpatient and outpatient status
  • Informed consent: Patients who are able to give informed written consent in person (i.e. patients who are capable of giving informed written consent on one's own)
  • Limited prior exposure to low or moderate doses of L-dopa (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 4 weeks prior to screening.

Exclusion Criteria:

  • Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder).

The seriousness refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).

  • Patients with symptomatic postural hypotension. (e.g. dizziness and syncope).
  • Patients who have had serious psychiatric symptoms (e.g. confusion, hallucination, delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-Parkinson drugs).
  • Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week-4 to Week0.

    • Anticholinergic agents: trihexyphenidyl hydrochloride (e.g. Artane®), piroheptine hydrochloride (Trimol®), mazaticol hydrochloride (Pentona®), metixene hydrochloride (Cholinfall®), biperiden hydrochloride (Akineton®), profenamine (Parkin®)
    • amantadine hydrochloride (e.g. Symmetrel®)
    • droxidopa (Dops®)
    • citicoline (e.g. Nicholin®)
    • selegiline hydrochloride (FP®)
    • zonisamide
    • estrogen: estriol (e.g.Estriel®)
    • CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine)
  • Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation, behaviour, and mood)
  • Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug.
  • Patients with current history or complication of carcinoma or malignant tumour.
  • Patients who have history of drug allergy to ropinirole hydrochloride (HCl).
  • Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation).
  • Patients who have been treated with any other investigational drug within
  • weeks prior to the treatment phase.
  • Others whom the investigator (sub investigator) considers ineligible for the study.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00434304
Study Director, GSK
ROP106064
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2009

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