REQUIP RLS Post Marketing Surveillance

NCT ID: NCT01327339

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 755 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-01
• Study Completion Date: 2009-11-30

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.

Conditions

Restless Legs Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects eligible for REQUIP prescription

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

Ropinirole

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Subjects with hypersensitivity to ropinirole and any excipients
• Female who is during the period of the pregnancy or who are lactating

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Ji-Yun Kim BA, Shin-Young Oh MS, Han-Kyu Lee MD, MS and Dr. Yil-Seob Lee MD, PhD. A Post-marketing Surveillance to Monitor the Safety of Ropinirole (Requip) in Korean Patients with Restless Legs Syndrome. [JPERM]. 2012;5:25-30.

Reference Type: BACKGROUND

Other Identifiers

106207

Identifier Type: -

Identifier Source: org_study_id