ID
44355
Beschrijving
Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome
Trefwoorden
Versies (2)
- 05-03-19 05-03-19 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)
Screening
- StudyEvent: ODM
Beschrijving
RLS Screen History
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C0220908
- UMLS CUI-3
- C0262926
Beschrijving
Restless Legs Syndrome, Age of Onset
Datatype
integer
Maateenheden
- years
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0206132
Beschrijving
Restless Legs Syndrome, Pharmaceutical Preparations, Relationships
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0439849
Beschrijving
Restless Legs Syndrome, Pharmaceutical Preparations, Relationships
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0439849
Beschrijving
Restless Legs Syndrome, During, Pregnancy
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0032961
Beschrijving
Limb movement, Sleep
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0596840
- UMLS CUI [1,2]
- C0037313
Beschrijving
Limb movement, Sleep, Age of Onset
Datatype
integer
Maateenheden
- years
Alias
- UMLS CUI [1,1]
- C0596840
- UMLS CUI [1,2]
- C0037313
- UMLS CUI [1,3]
- C0206132
Beschrijving
Alcohol consumption
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
Alcohol consumption, alcohol units/week
Datatype
integer
Maateenheden
- Units/week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschrijving
Caffeine consumption
Datatype
boolean
Alias
- UMLS CUI [1]
- C0948365
Beschrijving
Caffeine consumption, cups of coffee consumed per day (___cups/day)
Datatype
integer
Maateenheden
- cups/day
Alias
- UMLS CUI [1,1]
- C0948365
- UMLS CUI [1,2]
- C2164136
Beschrijving
f ’Yes’ please record on the Significant Medical/Surgical History and Physical Examination page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0851578
Beschrijving
Restless Legs Syndrome, Family History
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0241889
Beschrijving
Limb movement, Sleep, Family History
Datatype
text
Alias
- UMLS CUI [1,1]
- C0596840
- UMLS CUI [1,2]
- C0037313
- UMLS CUI [1,3]
- C0241889
Beschrijving
Restless Legs Syndrome; Symptoms; Temporal periods of day
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0439548
Beschrijving
RLS Diagnostic Criteria
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C0679228
Beschrijving
Restless Legs Syndrome, limb movement, desire; Restless Legs Syndrome, Paresthesia; Restless Legs Syndrome, Dysesthesia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0596840
- UMLS CUI [1,3]
- C0871633
- UMLS CUI [2,1]
- C0035258
- UMLS CUI [2,2]
- C0030554
- UMLS CUI [3,1]
- C0035258
- UMLS CUI [3,2]
- C0392699
Beschrijving
Restless Legs Syndrome, Motor Restlessness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0700075
Beschrijving
Restless Legs Syndrome, Symptoms, Rest; Restless Legs Syndrom, Physical activity, Feeling relief
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0035253
- UMLS CUI [2,1]
- C0035258
- UMLS CUI [2,2]
- C0026606
- UMLS CUI [2,3]
- C0564405
Beschrijving
Restless Legs Syndrome, Symptoms, Temporal periods of day
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0439548
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Body Height
Datatype
text
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Body Height
Datatype
float
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Body Weight
Datatype
text
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Systolic pressure, Sitting position
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschrijving
Diastolic blood pressure, Sitting position
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschrijving
Orthostatic Vital Signs
Alias
- UMLS CUI-1
- C1827287
Beschrijving
Semi-erect; Vital Signs Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C2826762
Beschrijving
Semi-erect; Systolic Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
Beschrijving
Semi-erect; Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
Beschrijving
Semi-erect; Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
Beschrijving
Erect, Vital Signs Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C2826762
Beschrijving
Erect, Systolic Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
Beschrijving
Erect, Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
Beschrijving
Erect, Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
Beschrijving
Electrocardiogram (12 Lead)
Alias
- UMLS CUI-1
- C0430456
Beschrijving
12 lead ECG, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschrijving
If ’Yes’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0220825
Beschrijving
Collection of blood specimen for laboratory procedure, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
Laboratory Procedures, Laboratory specimen identification label
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C4273937
Beschrijving
If ’Yes’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1704258
Beschrijving
Urine Dipstick
Alias
- UMLS CUI-1
- C0430370
Beschrijving
If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and send a sample to Quest Diagnostics for further evaluation.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
Pregnancy Dipstick
Alias
- UMLS CUI-1
- C0430056
Beschrijving
Childbearing Potential
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
Beschrijving
If ’Positive’, please record details on the Significant Medical/ Surgical History and Physical Examination and exclude the patient.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0456984
Beschrijving
Significant Medical/Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Beschrijving
f 'Yes' , please list below one diagnosis per line. (Please print clearly)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0489540
Beschrijving
Medical History, Diagnosis; History of surgical procedures, Diagnosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C0011900
Beschrijving
Medical History, Diagnosis, Year; History of surgical procedures, Diagnosis, Year
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0439234
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C0011900
- UMLS CUI [2,3]
- C0439234
Beschrijving
Medical History, Diagnosis, Current, Past; History of surgical procedures, Diagnosis, Current, Past
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0521116
- UMLS CUI [1,4]
- C1444637
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C0011900
- UMLS CUI [2,3]
- C0521116
- UMLS CUI [2,4]
- C1444637
Beschrijving
Prior and Concomitant Medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-3
- C2347852
Beschrijving
If ‘Yes’, please record details below (Please print clearly)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Pharmaceutical Preparations, Medication name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Beschrijving
Pharmaceutical Preparations, Daily Dose, Total
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Beschrijving
Pharmaceutical Preparations, Disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0012634
Beschrijving
Pharmaceutical Preparation, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Pharmaceutical Preparation, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Pharmaceutical Preparations, Continuous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschrijving
RLS Pharmacotherapy History
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0262926
Beschrijving
If ‘Yes’, please record details below (Please print clearly)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0262926
Beschrijving
Restless Legs Syndrome, Pharmaceutical Preparations, Medication name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C2360065
Beschrijving
Restless Legs Syndrome, Pharmaceutical Preparations, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0808070
Beschrijving
Restless Legs Syndrome, Pharmaceutical Preparations, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0806020
Beschrijving
Restless Legs Syndrome, Pharmaceutical Preparations, Continuous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0549178
Beschrijving
Restless Legs Syndrome, Drug Treatment and Response to Therapy
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0150839
Beschrijving
Restless Legs Syndrome, Pharmaceutical Preparations, Physical tolerance to drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0556444
Beschrijving
Screening Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Restless Legs Syndrome, Diagnosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0011900
Beschrijving
Age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Restless Legs Syndrome, Daytime
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0332169
Beschrijving
Primary Sleep Disorders
Datatype
boolean
Alias
- UMLS CUI [1]
- C0236991
Beschrijving
Movement Disorders
Datatype
boolean
Alias
- UMLS CUI [1]
- C0026650
Beschrijving
Disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Ropinirole, Intolerance to substance; Dopamine Agonists, Intolerance to substance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0244821
- UMLS CUI [1,2]
- C1744706
- UMLS CUI [2,1]
- C0178601
- UMLS CUI [2,2]
- C1744706
Beschrijving
Substance Use Disorders; Substance Dependence
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
- UMLS CUI [2]
- C0038580
Beschrijving
Female, Childbearing Potential, Contraceptive methods
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C3831118
- UMLS CUI [1,3]
- C0700589
Beschrijving
Female, Pregnancy; Female, Breast Feeding
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C0032961
- UMLS CUI [2,1]
- C0086287
- UMLS CUI [2,2]
- C0006147
Beschrijving
Disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Non-Compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C0457432
Similar models
Screening
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C0220908 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0206132 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,3])
C0560579 (UMLS CUI [1,2])
C2164136 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
C0679228 (UMLS CUI-2)
C0596840 (UMLS CUI [1,2])
C0871633 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0030554 (UMLS CUI [2,2])
C0035258 (UMLS CUI [3,1])
C0392699 (UMLS CUI [3,2])
C0700075 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0564405 (UMLS CUI [2,3])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C2826762 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C2826762 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C4273937 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0489540 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0011900 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0439234 (UMLS CUI [2,3])
C0011900 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,4])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C1444637 (UMLS CUI [2,4])
C2347852 (UMLS CUI-3)
C2360065 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0013227 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0150839 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0556444 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,2])
C1744706 (UMLS CUI [1,2])
C0178601 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
C0038580 (UMLS CUI [2])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,2])
C0086287 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])