REQUIP RLS Post Marketing Surveillance | Clinical Trial

Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropinirole

Drug

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.

Primary outcomes

Number of Participants With Any Adverse Event

Time frame: 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 outcomes

Number of Participants With Any Serious Adverse Event

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: REQUIP RLS PMS

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Apr 1, 2011
Registry last updated: Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed