ID
40830
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)
- 5/19/20 5/19/20 -
- 5/20/20 5/20/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 20, 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)
Predose Restriction List; Meals and Fluid Intake
- StudyEvent: ODM
Description
Predose Restriction List
Alias
- UMLS CUI-1
- C0439565
- UMLS CUI-2
- C1707357
Description
1.Has the subject fasted from all food and drink (except water) for at least 4 hours prior to any clinical safety labs?
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
2. Has the subject maintained their normal smoking habit?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519386
Description
3. Has the subject refrained from consuming xanthine-containing foods and beverages?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0043314
- UMLS CUI [1,2]
- C0016452
- UMLS CUI [1,3]
- C0443288
Description
4. Has the subject refrained from consuming food containing CYP1A2 inducing constituents?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1827490
- UMLS CUI [1,2]
- C0443288
- UMLS CUI [1,3]
- C0016452
Description
5. Has the subject refrained from taking quinine?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034417
- UMLS CUI [1,2]
- C0443288
Description
6. Has the subject refrained from alcohol?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Description
7.Prescription of drug (procedure) | OTC - Over The Counter; Pharmaceutical Preparations | Vitamins | Minerals | Medicinal Herbs | Interferes with; Procedure (set of actions) | compromise; patient safety
Data type
text
Alias
- UMLS CUI [1]
- C2239117
- UMLS CUI [2,1]
- C2709201
- UMLS CUI [2,2]
- C0013227
- UMLS CUI [3]
- C0042890
- UMLS CUI [4]
- C0026162
- UMLS CUI [5]
- C0025125
- UMLS CUI [6,1]
- C0521102
- UMLS CUI [6,2]
- C2700391
- UMLS CUI [7,1]
- C2945640
- UMLS CUI [7,2]
- C1113679
Description
8. Has the subject refrained from taking antacids?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0003138
- UMLS CUI [1,2]
- C0443288
Description
Meals and Fluid Intake
Alias
- UMLS CUI-1
- C1998602
- UMLS CUI-2
- C0429791
Description
Meals and Fluid Intake - Timepoint
Data type
integer
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0429791
- UMLS CUI [1,3]
- C2348792
Description
Meals and Fluid Intake - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0429791
- UMLS CUI [1,3]
- C0011008
Description
Actual time meal completed
Data type
time
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0040223
Description
Did subject complete meal?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0205197
Description
Meals and Fluid Intake - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0429791
- UMLS CUI [1,3]
- C0947611
Description
Did subject have a drink?
Data type
boolean
Alias
- UMLS CUI [1]
- C0452428
Description
Meals and Fluid Intake
Alias
- UMLS CUI-1
- C1998602
- UMLS CUI-2
- C0429791
Description
Meals and Fluid Intake - Timepoint
Data type
integer
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0429791
- UMLS CUI [1,3]
- C2348792
Description
Meals and Fluid Intake - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0429791
- UMLS CUI [1,3]
- C0011008
Description
Actual time meal completed
Data type
time
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0040223
Description
Did subject complete meal?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0205197
Description
Meals and Fluid Intake - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0429791
- UMLS CUI [1,3]
- C0947611
Description
Did subject have a drink?
Data type
boolean
Alias
- UMLS CUI [1]
- C0452428
Similar models
Predose Restriction List; Meals and Fluid Intake
- StudyEvent: ODM
C1707357 (UMLS CUI-2)
C0016452 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
C0443288 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
C0443288 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,2])
C2709201 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0042890 (UMLS CUI [3])
C0026162 (UMLS CUI [4])
C0025125 (UMLS CUI [5])
C0521102 (UMLS CUI [6,1])
C2700391 (UMLS CUI [6,2])
C2945640 (UMLS CUI [7,1])
C1113679 (UMLS CUI [7,2])
C0443288 (UMLS CUI [1,2])
C0429791 (UMLS CUI-2)
C0429791 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C0429791 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0429791 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0429791 (UMLS CUI-2)
C0429791 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C0429791 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0429791 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])