Last updated: 11/03/2018 08:44:16

REQUIP RLS Post Marketing SurveillanceREQUIP RLS PMS

GSK study ID
106207
See study documents
Clinicaltrials.gov ID
NCT01327339
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with any adverse event

Timeframe: one month

Secondary outcomes:

Number of participants with any serious adverse event

Timeframe: one month

Number of participants with the indicated unexpected adverse events

Timeframe: one month

Interventions:
Drug: Ropinirole
Enrollment:
755
Observational study model:
Cohort
Primary completion date:
2009-30-11
Time perspective:
Prospective
Clinical publications:
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.
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
April 2006 to November 2009
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
  • Subjects diagnosed with RLS by the investigator
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol
  • 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.
Inclusion and exclusion 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

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2009-30-11
Actual study completion date
2009-30-11

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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