REQUIP RLS Post Marketing Surveillance

NCT01327339 | Completed Results

• 1 other identifier: 106207
• Study Type: observational
• Target: 755
• Locations: 0 countries
• Sites: N/A

Brief Summary

post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  one month

Secondary Outcomes (2)

• Number of Participants With Any Serious Adverse Event

  one month

• Number of Participants With the Indicated Unexpected Adverse Events

  one month

Study Arms (1)

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.

Drug: Ropinirole

Interventions

Ropinirole DRUG

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.

Subjects eligible for REQUIP prescription

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.

You may qualify if:

• 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

You may not qualify if:

• Subjects with hypersensitivity to ropinirole and any excipients
• Female who is during the period of the pregnancy or who are lactating

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: April 1, 2011
• Study Start: April 1, 2006
• Primary Completion: November 30, 2009
• Study Completion: November 30, 2009
• Last Updated: September 12, 2017
• Results First Posted: April 1, 2011

Record last verified: 2017-08