N/A
Completed N=755
REQUIP RLS Post Marketing Surveillance
Source: ClinicalTrials.gov NCT01327339 ↗Enrolled (actual)
755
Serious AEs
0.4%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants With Any Adverse Event — 44 participants
Summary
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event |
44 | — |
| SECONDARY Number of Participants With Any Serious Adverse Event |
3 | — |
| SECONDARY Number of Participants With the Indicated Unexpected Adverse Events |
2; 1; 1; 1; 1; 1 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01327339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.