REQUIP RLS Post Marketing Surveillance

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Ropinirole

• Registration Number: NCT01327339
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2006-04-01
• Primary Completion: 2009-11-30
• Study Completion: 2009-11-30
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Results First Submitted: 2011-03-03
• Results First Submitted QC: 2011-03-03
• Study First Posted: 2011-04-01
• Results First Posted: 2011-04-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 755

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects eligible for REQUIP prescription	Ropinirole	Male and female subjects who were considered appropriate to be prescribed REQUIP according to the prescribing information will be included in this study.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Any Adverse Event	one month	An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Any Serious Adverse Event	one month	A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Number of Participants With the Indicated Unexpected Adverse Events	one month	An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.