REQUIP RLS Post Marketing Surveillance (REQUIP RLS PMS)
|ClinicalTrials.gov Identifier: NCT01327339|
Recruitment Status : Completed
First Posted : April 1, 2011
Results First Posted : April 1, 2011
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment|
|Restless Legs Syndrome||Drug: Ropinirole|
|Study Type :||Observational|
|Actual Enrollment :||755 participants|
|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|
|Actual Study Start Date :||April 1, 2006|
|Actual Primary Completion Date :||November 30, 2009|
|Actual Study Completion Date :||November 30, 2009|
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.
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327339
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|