GSK: Protocol Summary for ROP106064

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Protocol Summary for ROP106064

Protocol Summary
Protocol Id:	ROP106064
Secondary Ids:	N/A
Title:	Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -
Phase:	phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Japan: Ministry of Health , Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency
Collaborators:	N/A
Brief Summary:	This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.
Detailed Description:
Record Verification Date:	June 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	April 2007
Study Completion Date:	March 2009
Study Completion Date Type:	Actual
Primary Completion Date:	March 2009
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Single Group Assignment
Study Classification (Endpoint):	Pharmacokinetics/dynamics Study
Primary Outcomes:	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 24 Hours
Secondary Outcomes:	Laboratory tests (haematology, biochemistry and urine) week 0-52 Vital signs (blood pressure, pulse rate) week 0-52 Japanese UPDRS(PartⅠ,Ⅱ,Ⅲ and Ⅳ) week 0-52 Clinician's global impression on efficacy week 0-52 Electrocardiography (Standard 12-Lead ECG) week 0-52 Adverse events week 0-52 Proportion of subjects who continuously participated in the study week 0-52 Modified Hoehn & Yahr criteria stages week 0-52
Conditions:	Parkinson Disease
Keywords:	Parkinson's Disease PD
Eligibility Criteria:	Click to view inclusion/exclusion criteria 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 Week 0. • 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 12weeks prior to the treatment phase. •Others whom the investigator (sub investigator) considers ineligible for the study.
Gender:	Both
Minimum Age:	20 Year
Maximum Age:
Enrollment:	62
Enrollment Type:	Actual
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	No locations currently recruiting for this study.

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Protocol Summary for ROP106064