GSK: Protocol Summary for 106207

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Protocol Summary for 106207

Protocol Summary
Protocol Id:	106207
Secondary Ids:
Title:	An open-label, multi-centre, observational, post-marketing surveillance to monitor the safety of REQUIP(ropinirole) administered in Korean restless leg syndrome patients according to the prescribing information
Phase:	phase 4
Acronym:	REQUIP RLS PMS
FDA Regulated Intervention?:	No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Observational
Oversight Authority:	Korea Food and Drug Administration
Collaborators:
Brief Summary:	post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
Detailed Description:	This study is a post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS(restless leg syndrome) and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of ropinirole in real clinical practices after marketing. The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
Record Verification Date:	March 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	April 2006
Study Completion Date:	November 2009
Study Completion Date Type:	Actual
Primary Completion Date:	November 2009
Primary Completion Date Type:	Actual
Study Design:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:	None retained
Biospecimen Description:
Primary Outcomes:	overall incidences of AEs one month
Secondary Outcomes:	the incidences of unexpected AEs one month the incidences of serious adverse events one month
Conditions:	Restless Legs Syndrome
Keywords:
Study Population:	The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
Sampling Method:	Probability
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: • Subjects diagnosed with RLS by the investigator • Subjects who the investigator believes that they can and will comply with the requirements of the protocol -To be contactable over the phone -To follow the administration regimen. • A male or female aged 18 years and more at the time of the first prescription. • Subjects with no experience of RLS treatment using ropinirole Exclusion Criteria: Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. GSK Korea encourage the doctors participating this study to enrol the subjects prescribed with Ropinirole following the locally approved Prescribing Information (Appendix ) The following criteria should be checked at the time of study entry. • Subjects with hypersensitivity to ropinirole and any excipients • Female who is during the period of the pregnancy or who are lactating
Gender:	Both
Minimum Age:
Maximum Age:
Enrollment:
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 106207