ID

40830

Beschreibung

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

Stichworte

Versionen (2)
  1. 19.05.20 19.05.20 -
  2. 20.05.20 20.05.20 -
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GlaxoSmithKline

Hochgeladen am

20. Mai 2020

DOI

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

Englisch

Predose Restriction List; Meals and Fluid Intake

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Predose Restriction List
Beschreibung

Predose Restriction List

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C1707357
1.Has the subject fasted from all food and drink (except water) for at least 4 hours prior to any clinical safety labs?
Beschreibung

1.Has the subject fasted from all food and drink (except water) for at least 4 hours prior to any clinical safety labs?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
2. Has the subject maintained their normal smoking habit?
Beschreibung

2. Has the subject maintained their normal smoking habit?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519386
3. Has the subject refrained from consuming xanthine-containing foods and beverages?
Beschreibung

3. Has the subject refrained from consuming xanthine-containing foods and beverages?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043314
UMLS CUI [1,2]
C0016452
UMLS CUI [1,3]
C0443288
4. Has the subject refrained from consuming food containing CYP1A2 inducing constituents?
Beschreibung

4. Has the subject refrained from consuming food containing CYP1A2 inducing constituents?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1827490
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C0016452
5. Has the subject refrained from taking quinine?
Beschreibung

5. Has the subject refrained from taking quinine?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034417
UMLS CUI [1,2]
C0443288
6. Has the subject refrained from alcohol?
Beschreibung

6. Has the subject refrained from alcohol?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
7. Has the subject been prescribed medication for the first time within 14 days or over-the- counter (OTC) medicine within 7 days (except HRT and OCPs), or vitamins, minerals and herbal remedies within 48 hours before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject’s safety? A subject must have been taking their prescribed HRT or OCP for at least 2 days before the first dose of study medication.
Beschreibung

7.Prescription of drug (procedure) | OTC - Over The Counter; Pharmaceutical Preparations | Vitamins | Minerals | Medicinal Herbs | Interferes with; Procedure (set of actions) | compromise; patient safety

Datentyp

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
8. Has the subject refrained from taking antacids?
Beschreibung

8. Has the subject refrained from taking antacids?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003138
UMLS CUI [1,2]
C0443288
Meals and Fluid Intake
Beschreibung

Meals and Fluid Intake

Alias
UMLS CUI-1
C1998602
UMLS CUI-2
C0429791
Meals and Fluid Intake - Timepoint
Beschreibung

Meals and Fluid Intake - Timepoint

Datentyp

integer

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0429791
UMLS CUI [1,3]
C2348792
Meals and Fluid Intake - Date
Beschreibung

Meals and Fluid Intake - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0429791
UMLS CUI [1,3]
C0011008
Actual time meal completed
Beschreibung

Actual time meal completed

Datentyp

time

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0040223
Did subject complete meal?
Beschreibung

Did subject complete meal?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
Meals and Fluid Intake - Comments
Beschreibung

Meals and Fluid Intake - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0429791
UMLS CUI [1,3]
C0947611
Did subject have a drink?
Beschreibung

Did subject have a drink?

Datentyp

boolean

Alias
UMLS CUI [1]
C0452428
Meals and Fluid Intake
Beschreibung

Meals and Fluid Intake

Alias
UMLS CUI-1
C1998602
UMLS CUI-2
C0429791
Meals and Fluid Intake - Timepoint
Beschreibung

Meals and Fluid Intake - Timepoint

Datentyp

integer

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0429791
UMLS CUI [1,3]
C2348792
Meals and Fluid Intake - Date
Beschreibung

Meals and Fluid Intake - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0429791
UMLS CUI [1,3]
C0011008
Actual time meal completed
Beschreibung

Actual time meal completed

Datentyp

time

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0040223
Did subject complete meal?
Beschreibung

Did subject complete meal?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
Meals and Fluid Intake - Comments
Beschreibung

Meals and Fluid Intake - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0429791
UMLS CUI [1,3]
C0947611
Did subject have a drink?
Beschreibung

Did subject have a drink?

Datentyp

boolean

Alias
UMLS CUI [1]
C0452428
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Ähnliche Modelle

Predose Restriction List; Meals and Fluid Intake

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Predose Restriction List
C0439565 (UMLS CUI-1)
C1707357 (UMLS CUI-2)
1.Has the subject fasted from all food and drink (except water) for at least 4 hours prior to any clinical safety labs?
Item
1.Has the subject fasted from all food and drink (except water) for at least 4 hours prior to any clinical safety labs?
boolean
C0015663 (UMLS CUI [1])
2. Has the subject maintained their normal smoking habit?
Item
2. Has the subject maintained their normal smoking habit?
boolean
C1519386 (UMLS CUI [1])
3. Has the subject refrained from consuming xanthine-containing foods and beverages?
Item
3. Has the subject refrained from consuming xanthine-containing foods and beverages?
boolean
C0043314 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
4. Has the subject refrained from consuming food containing CYP1A2 inducing constituents?
Item
4. Has the subject refrained from consuming food containing CYP1A2 inducing constituents?
boolean
C1827490 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
5. Has the subject refrained from taking quinine?
Item
5. Has the subject refrained from taking quinine?
boolean
C0034417 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
6. Has the subject refrained from alcohol?
Item
6. Has the subject refrained from alcohol?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
7.Prescription of drug (procedure) | OTC - Over The Counter; Pharmaceutical Preparations | Vitamins | Minerals | Medicinal Herbs | Interferes with; Procedure (set of actions) | compromise; patient safety
Item
7. Has the subject been prescribed medication for the first time within 14 days or over-the- counter (OTC) medicine within 7 days (except HRT and OCPs), or vitamins, minerals and herbal remedies within 48 hours before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject’s safety? A subject must have been taking their prescribed HRT or OCP for at least 2 days before the first dose of study medication.
text
C2239117 (UMLS CUI [1])
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])
8. Has the subject refrained from taking antacids?
Item
8. Has the subject refrained from taking antacids?
boolean
C0003138 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Item Group
Meals and Fluid Intake
C1998602 (UMLS CUI-1)
C0429791 (UMLS CUI-2)
Item
Meals and Fluid Intake - Timepoint
integer
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Intake Timepoint
Code List
Meals and Fluid Intake - Timepoint
CL Item
Breakfast 8 AM (1)
CL Item
Lunch 11:30 AM - 12 PM (2)
CL Item
Evening Meal 7 - 7:30 PM (3)
CL Item
Snack ~11 PM (Prior to Bedtime) (4)
Meals and Fluid Intake - Date
Item
Meals and Fluid Intake - Date
date
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Actual time meal completed
Item
Actual time meal completed
time
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Did subject complete meal?
Item
Did subject complete meal?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Meals and Fluid Intake - Comments
Item
Meals and Fluid Intake - Comments
text
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Did subject have a drink?
Item
Did subject have a drink?
boolean
C0452428 (UMLS CUI [1])
Item Group
Meals and Fluid Intake
C1998602 (UMLS CUI-1)
C0429791 (UMLS CUI-2)
Item
Meals and Fluid Intake - Timepoint
integer
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Meals and Fluid Intake - Timepoint
Code List
Meals and Fluid Intake - Timepoint
CL Item
Breakfast 8 AM  (1)
CL Item
Lunch 11:30 AM - 12 PM  (2)
CL Item
Afternoon Meal 5 PM  (3)
CL Item
Snack ~8 PM (4)
Meals and Fluid Intake - Date
Item
Meals and Fluid Intake - Date
date
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Actual time meal completed
Item
Actual time meal completed
time
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Did subject complete meal?
Item
Did subject complete meal?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Meals and Fluid Intake - Comments
Item
Meals and Fluid Intake - Comments
text
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Did subject have a drink?
Item
Did subject have a drink?
boolean
C0452428 (UMLS CUI [1])
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