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post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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.
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The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Requip 0.25 mg, 1 mg, 2 mg | Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments. | Posted | Number | participants | one month |
|
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Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Requip 0.25 mg, 1 mg, 2 mg | Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Melena | Gastrointestinal disorders | WHOART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | WHOART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
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| 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. | one month |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments. | Number | participants |
|
| Participants |
|
|
|
| Secondary | 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. | ITT Population | Posted | Number | participants | one month |
|
|
|
| Secondary | 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. | ITT Population | Posted | Number | participants | one month |
|
|
|
| 3 |
| 747 |
| 44 |
| 747 |
| Appendicitis | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Dizziness | Nervous system disorders | WHOART | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Dizziness | Nervous system disorders | WHOART | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Chest Pain | General disorders | WHOART | Systematic Assessment |
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| Somnolence | Psychiatric disorders | WHOART | Systematic Assessment |
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| Dysesthesia | Nervous system disorders | WHOART | Systematic Assessment |
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| Headache | General disorders | WHOART | Systematic Assessment |
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| Weight Decrease | Metabolism and nutrition disorders | WHOART | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Fatigue | General disorders | WHOART | Systematic Assessment |
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| Sleep Disturbed | Psychiatric disorders | WHOART | Systematic Assessment |
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| Thirsty | Metabolism and nutrition disorders | WHOART | Systematic Assessment |
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| Eye Pain | Eye disorders | WHOART | Systematic Assessment |
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| Hypotension | Cardiac disorders | WHOART | Systematic Assessment |
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| Saliva Increased | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Dystonia | General disorders | WHOART | Systematic Assessment |
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| Edema | General disorders | WHOART | Systematic Assessment |
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| Tremor, Pain | General disorders | WHOART | Systematic Assessment |
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| Amnesia | Psychiatric disorders | WHOART | Systematic Assessment |
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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.
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Saliva Increased |
|
| Melena |
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| Amnesia |
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| Appendicitis |
|