GSK: Protocol Summary for 101468/248

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Protocol Summary for 101468/248

Protocol Summary
Protocol Id:	101468/248
Secondary Ids:
Title:	An Open-Label Extension Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CDER
IND/IDE Number:	60,503
IND/IDE Serial Number:	0065
Has Expanded Access?:
Study Type:	Interventional
Oversight Authority:	Belgium: Directorate general for the protection of Public health: Medicines Hungary: National Institute of Pharmacy Czech Republic: State Institute for Drug Control United States: Food and Drug Administration
Collaborators:
Brief Summary:	To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease
Detailed Description:
Record Verification Date:	March 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	February 2004
Study Completion Date:	March 2010
Study Completion Date Type:	Actual
Primary Completion Date:	March 2010
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Non-randomized
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Single Group Assignment
Study Classification (Endpoint):	Safety Study
Primary Outcomes:	To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson''''s disease. 6 years
Secondary Outcomes:	Additionally, patient preferences with regards to once daily versus three times daily dosing will be summarised. 6 years To collect patient preference data regarding once daily versus three times daily dosing. 6 years
Conditions:	Parkinson Disease
Keywords:	ropinirole CR ropinirole IR open-label REQUIP efficacy ropinirole XL Parkinson's disease safety long term safety
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: • Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal). • Subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study 248. • Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System). • Provide written informed consent for this study. • Be willing and able to comply with study procedures. Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: • Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies. • Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma). • Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169). • Subjects with severe dizziness or fainting due to postural hypotension on standing. • Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome P 450 1A2 (CYP1A2 [e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol]) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period. • Women who are pregnant or breast-feeding. • Use of an investigational drug throughout the treatment period.
Gender:	Both
Minimum Age:	30 Year
Maximum Age:
Enrollment:	419
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:	Click to view location information Belgium (click to view all sites in Belgium) GSK Investigational Site Bruxelles, 1200; Completed; GSK Investigational Site Roeselare, 8800; Completed; GSK Investigational Site Hoboken, 2660; Completed; GSK Investigational Site Leuven, 3000; Completed; GSK Investigational Site Hasselt, 3500; Completed; Czech Republic (click to view all sites in Czech Republic) GSK Investigational Site Ostrava, 703 52; Completed; GSK Investigational Site Pardubice, 535 03; Completed; GSK Investigational Site Ostrava 10, 710 00; Completed; GSK Investigational Site Brno, 656 91; Completed; GSK Investigational Site Plzen - Lochotin, 304 60; Completed; GSK Investigational Site Prague, 100 34; Completed; GSK Investigational Site Hradec Kralove, 500 05; Completed; GSK Investigational Site Praha 2, 120 00; Completed; France (click to view all sites in France) GSK Investigational Site Rouffach, 68250; Completed; GSK Investigational Site Aix en Provence, 13616; Completed; GSK Investigational Site Lille Cedex, 59037; Completed; Hungary (click to view all sites in Hungary) GSK Investigational Site Budapest, 1204; Completed; GSK Investigational Site Miskolc, 3526; Completed; GSK Investigational Site Budapest, 1096; Completed; GSK Investigational Site Debrecen, H-4012; Completed; GSK Investigational Site Miskolc, 3529; Completed; GSK Investigational Site Pécs, 7623; Completed; GSK Investigational Site Budapest, 1083; Completed; GSK Investigational Site Vasvari Pal street 2, H=9023 Gyor, ; Completed; GSK Investigational Site Budapest, 1135; Completed; GSK Investigational Site Budapest, 1145; Completed; Italy (click to view all sites in Italy) GSK Investigational Site Pescara, Abruzzo, 65100; Completed; GSK Investigational Site Pozzilli (IS), Molise, 86077; Completed; GSK Investigational Site Grosseto, Toscana, 58100; Completed; GSK Investigational Site Lido Di Camaiore (LU), Toscana, 55043; Completed; GSK Investigational Site Vicenza, Veneto, 36057; Completed; Poland (click to view all sites in Poland) GSK Investigational Site Gdansk, 80-299; Completed; GSK Investigational Site Krakow, 31-530; Completed; GSK Investigational Site Gdansk, 80-211; Completed; GSK Investigational Site Poznan, 61-285; Completed; GSK Investigational Site Lublin, 20-954; Completed; GSK Investigational Site Lublin, 20-718; Completed; GSK Investigational Site Ciborz, 66-212; Completed; GSK Investigational Site Warsaw, 02-097; Completed; GSK Investigational Site Katowice, 40-752; Completed; GSK Investigational Site Bialystok, 15-276; Completed; GSK Investigational Site Warszawa, 01-337; Completed; GSK Investigational Site Torun, 87-100; Completed; GSK Investigational Site Leszno, 64-100; Completed; Spain (click to view all sites in Spain) GSK Investigational Site Barcelona, 08025; Completed; United Kingdom (click to view all sites in United Kingdom) GSK Investigational Site Swansea, SA6 6NL; Completed; GSK Investigational Site Glasgow, Lanarkshire, G51 4TF; Completed; GSK Investigational Site Blackpool, Lancashire, FY3 8BP; Completed; GSK Investigational Site Newcastle Upon Tyne, Northumberland, NE4 6BE; Completed; GSK Investigational Site Chertsey, Surrey, KT16 0QA; Completed; United States (click to view all sites in United States) Alabama (click to view) GSK Investigational Site Birmingham, Alabama, 35294; Completed; California (click to view) GSK Investigational Site Fountain Valley, California, 92708; Completed; GSK Investigational Site San Francisco, California, 94109; Completed; Colorado (click to view) GSK Investigational Site Englewood, Colorado, 80110; Completed; Florida (click to view) GSK Investigational Site Boca Raton, Florida, 33486; Completed; GSK Investigational Site St. Petersburg, Florida, 33701; Completed; GSK Investigational Site Panama City, Florida, 32405; Completed; GSK Investigational Site Tampa, Florida, 33606; Completed; GSK Investigational Site Port Orange, Florida, 32127; Completed; Georgia (click to view) GSK Investigational Site Atlanta, Georgia, 30342; Completed; GSK Investigational Site Augusta, Georgia, 30912; Completed; Illinois (click to view) GSK Investigational Site Glenview, Illinois, 60025; Completed; Kansas (click to view) GSK Investigational Site Kansas City, Kansas, 66160; Completed; Massachusetts (click to view) GSK Investigational Site Boston, Massachusetts, 02215; Completed; Michigan (click to view) GSK Investigational Site Bingham Farms, Michigan, 48025; Completed; GSK Investigational Site Southfield, Michigan, 48034; Completed; GSK Investigational Site Traverse City, Michigan, 49684; Completed; New York (click to view) GSK Investigational Site Albany, New York, 12205; Completed; North Carolina (click to view) GSK Investigational Site Durham, North Carolina, 27705; Completed; Ohio (click to view) GSK Investigational Site Toledo, Ohio, 43614-5809; Completed; Pennsylvania (click to view) GSK Investigational Site Philadelphia, Pennsylvania, 19107; Completed; GSK Investigational Site Upland, Pennsylvania, 19013; Completed; Texas (click to view) GSK Investigational Site San Antonio, Texas, 78229; Completed; GSK Investigational Site Wichita Falls, Texas, 76301; Completed; Wisconsin (click to view) GSK Investigational Site Milwaukee, Wisconsin, 53233; Completed;

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Protocol Summary for 101468/248