REQUIP RLS Post Marketing Surveillance (REQUIP RLS PMS)
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Purpose
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
| Condition | Intervention |
|---|---|
|
Restless Legs Syndrome |
Drug: Ropinirole |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Number of Participants With Any Adverse Event [ Time Frame: one month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Study Start Date: | April 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
-
Drug: Ropinirole
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01327339 History of Changes |
| Other Study ID Numbers: | 106207 |
| Study First Received: | March 3, 2011 |
| Results First Received: | March 3, 2011 |
| Last Updated: | March 3, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations |
Signs and Symptoms Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013