Trial Outcomes & Findings for REQUIP RLS Post Marketing Surveillance (NCT NCT01327339)

NCT ID: NCT01327339

Last Updated: 2017-09-12

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 755 participants
• Primary outcome timeframe: one month
• Results posted on: 2017-09-12

Participant Flow

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.

Participant milestones

Measure	Requip 0.25 mg, 1 mg, 2 mg 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.
Overall Study STARTED	755
Overall Study COMPLETED	747
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Requip 0.25 mg, 1 mg, 2 mg 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.
Overall Study Protocol Violation	8

Baseline Characteristics

REQUIP RLS Post Marketing Surveillance

Baseline characteristics by cohort

Measure	Requip 0.25 mg, 1 mg, 2 mg n=747 Participants Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Age, Continuous	60.9 Years STANDARD_DEVIATION 13.4 • n=93 Participants
Sex: Female, Male Female	440 Participants n=93 Participants
Sex: Female, Male Male	307 Participants n=93 Participants
Race/Ethnicity, Customized Korean	747 participants n=93 Participants
Race/Ethnicity, Customized Not Korean	0 participants n=93 Participants

PRIMARY outcome

Timeframe: one month

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

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.

Outcome measures

Measure	Requip 0.25 mg, 1 mg, 2 mg n=747 Participants Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Number of Participants With Any Adverse Event	44 participants

SECONDARY outcome

Timeframe: one month

Population: ITT Population

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.

Outcome measures

Measure	Requip 0.25 mg, 1 mg, 2 mg n=747 Participants Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Number of Participants With Any Serious Adverse Event	3 participants

SECONDARY outcome

Timeframe: one month

Population: ITT Population

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.

Outcome measures

Measure	Requip 0.25 mg, 1 mg, 2 mg n=747 Participants Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Number of Participants With the Indicated Unexpected Adverse Events Weight Decrease	2 participants
Number of Participants With the Indicated Unexpected Adverse Events Thirsty	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Eye Pain	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Saliva Increased	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Melena	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Amnesia	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Appendicitis	1 participants

Adverse Events

Requip 0.25 mg, 1 mg, 2 mg

Serious events: 3 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Measure	Requip 0.25 mg, 1 mg, 2 mg n=747 participants at risk Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Gastrointestinal disorders Melena	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Appendicitis	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Abdominal Pain	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Nervous system disorders Dizziness	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.

Other adverse events

Measure	Requip 0.25 mg, 1 mg, 2 mg n=747 participants at risk Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
Psychiatric disorders Insomnia	1.7% 13/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Nausea	1.5% 11/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Nervous system disorders Dizziness	0.94% 7/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Vomiting	0.80% 6/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Chest Pain	0.40% 3/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Psychiatric disorders Somnolence	0.40% 3/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Nervous system disorders Dysesthesia	0.40% 3/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Headache	0.40% 3/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Metabolism and nutrition disorders Weight Decrease	0.27% 2/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Abdominal Pain	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Fatigue	0.27% 2/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Psychiatric disorders Sleep Disturbed	0.27% 2/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Metabolism and nutrition disorders Thirsty	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Eye disorders Eye Pain	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Cardiac disorders Hypotension	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Saliva Increased	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Dystonia	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Edema	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Tremor, Pain	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Psychiatric disorders Amnesia	0.13% 1/747 Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER