Restless Legs SyndromeREQUIP RLS PMSNCT01327339
REQUIP RLS Post Marketing Surveillance
An observational study of Restless Legs Syndrome, run by GlaxoSmithKline.
Trial summary
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Ropinirole
- How many people
- 755 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2006to 30 Nov 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
Read the detailed 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.
- Conditions
- Restless Legs Syndrome
- Being tested
- Ropinirole
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopiniroleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ropinirole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (2)
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.
Measured: one month
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study start1 Apr 2006
- Primary completion30 Nov 2009
- Study completion30 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327339
- Sponsor's protocol ID
- 106207
- Acronym
- REQUIP RLS PMS
- Status last verified
- Aug 2017
- First submitted
- 3 Mar 2011
- Last updated
- 12 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01327339
- Acronym / sponsor ID
- REQUIP RLS PMS / 106207
- Conditions
- Restless Legs Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 30 Nov 2009 (actual)
- Study completion
- 30 Nov 2009 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Posted 1 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects eligible for REQUIP prescription | – | Drug: RopiniroleMale and female subjects who were considered appropriate to be prescribed REQUIP according to the prescribing information will be included in this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
Key inclusion criteria (6 listed)
- Subjects diagnosed with RLS by the investigator
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopiniroleBasically 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. | Drug | Subjects eligible for REQUIP prescription |
Primary outcome
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.
2 secondary outcomes
Number of Participants With Any Serious Adverse Event
Time frame: one month
Number of Participants With the Indicated Unexpected Adverse Events
Time frame: one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundJi-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Adverse Event (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.