REQUIP RLS Post Marketing Surveillance (REQUIP RLS PMS)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Restless Legs Syndrome

Treatments: Drug: Ropinirole

Study type: Observational

Funder types: Industry

Identifiers

NCT01327339

106207

Details and patient eligibility

About

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

Full 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.

Enrollment: 755 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

755 participants in 1 patient group

Subjects eligible for REQUIP prescription

Description:

Male and female subjects who were considered appropriate to be prescribed REQUIP according to the prescribing information will be included in this study.

Treatment:

Drug: Ropinirole