GSK: Protocol Summary for ROX104805

Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for ROX104805

Protocol Summary for ROX104805

Protocol Summary
Protocol Id:	ROX104805
Secondary Ids:
Title:	A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting from Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients with Restless Legs Syndrome (RLS)
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CDER
IND/IDE Number:	70, 140
IND/IDE Serial Number:	0018
Has Expanded Access?:
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration
Collaborators:
Brief Summary:	This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Detailed Description:
Record Verification Date:	March 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	November 2005
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	adverse events (AE) post-conversion from ropinirole IR to ropinirole controlled-release for RLS
Secondary Outcomes:	Proportion discontinuing drug due to AEs after conversion from ropinirole IR to ropinirole controlled-release for RLS, analyses of AEs and vital signs, efficacy parameters(International RLS (IRLS) Rating Scale)
Conditions:	Restless Legs Syndrome
Keywords:	Ropinirole Restless Legs Syndrome RLS
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: •Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria. •Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily. •Subjects with RLS symptoms during both the evening and night or night time only. •Subjects who have given written informed consent to participate. Exclusion Criteria: •Subjects who require treatment of daytime RLS symptoms. •Signs of secondary RLS, serum ferritin level less than 10 mcg/L. •Movement Disorders, Clinically significant or unstable medical conditions. •Abnormal labs, electrocardiogram (ECG) or physical findings. •Receiving prohibited medications. •Sleeping habits incompatible with study design. •Intolerance to ropinirole or other dopamine agonist. •Pregnant or lactating. •Women of child-bearing potential who are not practicing an acceptable method of birth control.
Gender:	Both
Minimum Age:	18 Year
Maximum Age:	79 Year
Enrollment:	150
Enrollment Type:
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 United States (click to view all sites in United States) California (click to view) GSK Investigational Site Reseda, California, 91355; Completed; GSK Investigational Site Oxnard, California, 93030; Completed; GSK Investigational Site Pasadena, California, 91106; Completed; Florida (click to view) GSK Investigational Site Tampa, Florida, 33609; Completed; GSK Investigational Site St. Petersburg, Florida, 33701; Completed; GSK Investigational Site Boca Raton, Florida, 33486; Completed; Georgia (click to view) GSK Investigational Site Atlanta, Georgia, 30342; Completed; Illinois (click to view) GSK Investigational Site Oak Brook, Illinois, 60523; Completed; Kansas (click to view) GSK Investigational Site Lenexa, Kansas, 66214; Completed; Louisiana (click to view) GSK Investigational Site Baton Rouge, Louisiana, 70808; Completed; Massachusetts (click to view) GSK Investigational Site Springfield, Massachusetts, 01104; Completed; Michigan (click to view) GSK Investigational Site Bingham Farms, Michigan, 48025; Completed; Nevada (click to view) GSK Investigational Site Las Vegas, Nevada, 89119; Completed; New Hampshire (click to view) GSK Investigational Site Lebanon, New Hampshire, 03766; Completed; New Jersey (click to view) GSK Investigational Site Toms River, New Jersey, 08755; Completed; GSK Investigational Site Cherry Hill, New Jersey, 08003; Completed; New York (click to view) GSK Investigational Site New York, New York, 10021; Completed; GSK Investigational Site Plainview, New York, 11803; Completed; North Carolina (click to view) GSK Investigational Site Greenville, North Carolina, 27834; Completed; Ohio (click to view) GSK Investigational Site Dayton, Ohio, 46432; Completed; Oklahoma (click to view) GSK Investigational Site Oklahoma City, Oklahoma, 73112; Completed; Oregon (click to view) GSK Investigational Site Portland, Oregon, 97210; Completed; GSK Investigational Site Medford, Oregon, 97504-8456; Completed; South Carolina (click to view) GSK Investigational Site Columbia, South Carolina, 29201; Completed; Texas (click to view) GSK Investigational Site San Antonio, Texas, 78229; Completed; GSK Investigational Site Dallas, Texas, 75213; Completed; Washington (click to view) GSK Investigational Site Tacoma, Washington, 98405; Completed; GSK Investigational Site Walla Walla, Washington, 99362; Completed; Wisconsin (click to view) GSK Investigational Site Madison, Wisconsin, 53715; Completed;

Quick Search

Protocol Summary for ROX104805