REQUIP RLS Post Marketing Surveillance

Restless Legs Syndrome Clinical Trial

— REQUIP RLS PMS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327339
• Other study ID #: 106207
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: March 3, 2011
• Start date: April 2006
• Est. completion date: November 2009

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one month	No
Secondary	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.	one month	No
Secondary	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.	one month	No