REQUIP RLS PMS: REQUIP RLS Post Marketing Surveillance

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01327339
• Collaborator: (none)
• Enrollment: 755
• Actual Duration (Months): 44

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: Ropinirole

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

• Study Type: Observational
• Actual Enrollment: 755 participants
• 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
• Actual Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Nov 30, 2009
• Actual Study Completion Date: Nov 30, 2009

Arms and Interventions

Arm	Intervention/Treatment
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; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Any Adverse Event [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.

Secondary Outcome Measures

1. Number of Participants With Any Serious Adverse Event [one month]

   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.

2. Number of Participants With the Indicated Unexpected Adverse Events [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. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01327339
• Other Study ID Numbers: 106207
• First Posted: Apr 1, 2011
• Last Update Posted: Sep 12, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Ropinirole

Study Results

Participant Flow

Recruitment Details	The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Requip under the real clinical setting after launch.

Arm/Group Title	Requip 0.25 mg, 1 mg, 2 mg
Arm/Group Description	Requip tablet containing ropinirole hydrochloride equivalent to 0.25 milligrams (mg), 1 mg, 2 mg of ropinirole administered once daily. All subjects will be administered of Requip in normal prescription use. Dosage regimen can be changed by the investigator according to the prescribing information.
Period Title: Overall Study
STARTED	755
COMPLETED	747
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Requip 0.25 mg, 1 mg, 2 mg
Arm/Group Description	Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Overall Participants	747
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.9 (13.4)
Sex: Female, Male (Count of Participants)
Female	440 58.9%
Male	307 41.1%
Race/Ethnicity, Customized (participants) [Number]
Korean	747 100%
Not Korean	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Any Adverse Event
Description	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.
Time Frame	one month

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments.

Arm/Group Title	Requip 0.25 mg, 1 mg, 2 mg
Arm/Group Description	Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Measure Participants	747
Number [participants]	44 5.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Requip 0.25 mg, 1 mg, 2 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	5.9
	Confidence Interval	(2-Sided) 95%; 4.3 to 7.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants with an adverse event.

2. Secondary Outcome

Title	Number of Participants With Any Serious Adverse Event
Description	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.
Time Frame	one month

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Requip 0.25 mg, 1 mg, 2 mg
Arm/Group Description	Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Measure Participants	747
Number [participants]	3 0.4%

3. Secondary Outcome

Title	Number of Participants With the Indicated Unexpected Adverse Events
Description	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.
Time Frame	one month

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Requip 0.25 mg, 1 mg, 2 mg
Arm/Group Description	Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Measure Participants	747
Weight Decrease	2 0.3%
Thirsty	1 0.1%
Eye Pain	1 0.1%
Saliva Increased	1 0.1%
Melena	1 0.1%
Amnesia	1 0.1%
Appendicitis	1 0.1%

Adverse Events

Adverse Event Reporting Description	Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Arm/Group Title	Requip 0.25 mg, 1 mg, 2 mg
Arm/Group Description	Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
All Cause Mortality
	Requip 0.25 mg, 1 mg, 2 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Requip 0.25 mg, 1 mg, 2 mg
	Affected / at Risk (%)	# Events
Total	3/747 (0.4%)
Gastrointestinal disorders
Melena	1/747 (0.1%)
Appendicitis	1/747 (0.1%)
Abdominal Pain	1/747 (0.1%)
Nervous system disorders
Dizziness	1/747 (0.1%)
Other (Not Including Serious) Adverse Events
	Requip 0.25 mg, 1 mg, 2 mg
	Affected / at Risk (%)	# Events
Total	44/747 (5.9%)
Cardiac disorders
Hypotension	1/747 (0.1%)
Eye disorders
Eye Pain	1/747 (0.1%)
Gastrointestinal disorders
Nausea	11/747 (1.5%)
Vomiting	6/747 (0.8%)
Abdominal Pain	1/747 (0.1%)
Saliva Increased	1/747 (0.1%)
General disorders
Chest Pain	3/747 (0.4%)
Headache	3/747 (0.4%)
Fatigue	2/747 (0.3%)
Dystonia	1/747 (0.1%)
Edema	1/747 (0.1%)
Tremor, Pain	1/747 (0.1%)
Metabolism and nutrition disorders
Weight Decrease	2/747 (0.3%)
Thirsty	1/747 (0.1%)
Nervous system disorders
Dizziness	7/747 (0.9%)
Dysesthesia	3/747 (0.4%)
Psychiatric disorders
Insomnia	13/747 (1.7%)
Somnolence	3/747 (0.4%)
Sleep Disturbed	2/747 (0.3%)
Amnesia	1/747 (0.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.