REQUIP RLS Post Marketing Surveillance

GlaxoSmithKline755 enrolled

Overview

post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS

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 Type

OBSERVATIONAL

Enrollment

755

Conditions

Restless Legs Syndrome

Interventions

RopiniroleDRUG

Basically there is no treatment allocation. Subjects who would be administered of ropinirole at their physician's direction will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Any Adverse Event

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.

Time frame: one month

Secondary Outcomes

Number of Participants With Any Serious Adverse Event

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.

Time frame: one month

Number of Participants With the Indicated Unexpected Adverse Events

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.

Time frame: one month

Data from ClinicalTrials.gov

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