NCT01327339

REQUIP RLS Post Marketing Surveillance

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 755 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Ropinirole	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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-11-30
• Completion: 2009-11-30
• First posted: 2011-04-01
• Last updated: 2017-09-12
• Results posted: 2011-04-01