ID

40822

Description

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

Versions (2)
  1. 5/19/20 5/19/20 -
  2. 5/20/20 5/20/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 19, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

English

Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Factors
Description

Patient Factors

Alias
UMLS CUI-1
C1955348
What is your date of birth?
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical or patient-reported TYPE: Date by DD/MM/YYYY RESPONSE OPTIONS: DD/MM/YYYY

Data type

date

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0421451
Have you been told by a doctor that you have any of the following? 0 = I have no other diseases
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1298908
Have you been told by a doctor that you have any of the following? 1 = Heart disease (for example angina, heart attack, or heart failure)
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0018799
Have you been told by a doctor that you have any of the following? 2 = High blood pressure
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0020538
Have you been told by a doctor that you have any of the following? 3 = Leg pain when walking due to poor circulation
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1306889
Have you been told by a doctor that you have any of the following? 4 = Lung disease (for example asthma, chronic bronchitis, or emphysema)
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0024115
Have you been told by a doctor that you have any of the following? 5 = Diabetes
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0011849
Have you been told by a doctor that you have any of the following? 6 = Kidney disease
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0022658
Have you been told by a doctor that you have any of the following? 7 = Liver disease
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0023895
Have you been told by a doctor that you have any of the following? 8 = Problems caused by stroke
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0038454
Have you been told by a doctor that you have any of the following? 9 = Disease of the nervous system (for example Parkinson’s disease or multiple sclerosis)
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0027765
Have you been told by a doctor that you have any of the following? 10 = Other cancer (within the last 5 years)
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1707251
Have you been told by a doctor that you have any of the following? 11 = Depression
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0011581
Have you been told by a doctor that you have any of the following? 12 = Arthritis
Description

INCLUSION CRITERIA: All patients Based upon the Self-administered Comorbidity Questionnaire (Sangha et al, 2003) TIMING: Before treatment REPORTING SOURCE: patient-reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0003864
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Similar models

Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Item Group
Patient Factors
C1955348 (UMLS CUI-1)
Age
Item
What is your date of birth?
date
C0001779 (UMLS CUI [1])
C0421451 (UMLS CUI [2])
Comorbidities: No
Item
Have you been told by a doctor that you have any of the following? 0 = I have no other diseases
boolean
C0009488 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Comorbidities: Heart Disease
Item
Have you been told by a doctor that you have any of the following? 1 = Heart disease (for example angina, heart attack, or heart failure)
boolean
C0009488 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Comorbidities: High blood pressure
Item
Have you been told by a doctor that you have any of the following? 2 = High blood pressure
boolean
C0009488 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
Comorbidities: leg pain when walking due to poor circulation
Item
Have you been told by a doctor that you have any of the following? 3 = Leg pain when walking due to poor circulation
boolean
C0009488 (UMLS CUI [1,1])
C1306889 (UMLS CUI [1,2])
Comorbidities: Lung Disease
Item
Have you been told by a doctor that you have any of the following? 4 = Lung disease (for example asthma, chronic bronchitis, or emphysema)
boolean
C0009488 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
Comorbidities: Diabetes
Item
Have you been told by a doctor that you have any of the following? 5 = Diabetes
boolean
C0009488 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Comorbidities: Kidney Disease
Item
Have you been told by a doctor that you have any of the following? 6 = Kidney disease
boolean
C0009488 (UMLS CUI [1,1])
C0022658 (UMLS CUI [1,2])
Comorbidities: Liver Disease
Item
Have you been told by a doctor that you have any of the following? 7 = Liver disease
boolean
C0009488 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Comorbidities: Stroke
Item
Have you been told by a doctor that you have any of the following? 8 = Problems caused by stroke
boolean
C0009488 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
Comorbidities: Disease of the nervous system
Item
Have you been told by a doctor that you have any of the following? 9 = Disease of the nervous system (for example Parkinson’s disease or multiple sclerosis)
boolean
C0009488 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
Comorbidities: other cancer
Item
Have you been told by a doctor that you have any of the following? 10 = Other cancer (within the last 5 years)
boolean
C0009488 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
Comorbidities: Depression
Item
Have you been told by a doctor that you have any of the following? 11 = Depression
boolean
C0009488 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
Comorbidities: Arthritis
Item
Have you been told by a doctor that you have any of the following? 12 = Arthritis
boolean
C0009488 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
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