ID

40873

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 (1)
  1. 5/29/20 5/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 29, 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

Drug Tolerance; Dose Details

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Drug Tolerance
Description

Drug Tolerance

Alias
UMLS CUI-1
C0013220
Did the patient tolerate 0.125mg/0.25mg?
Description

Did the patient tolerate 0.125mg/0.25mg?

Data type

boolean

Alias
UMLS CUI [1]
C0013220
If patient did not tolerate the dose, enter the reason why
Description

If patient did not tolerate the dose, enter the reason why

Data type

text

Alias
UMLS CUI [1,1]
C0013220
UMLS CUI [1,2]
C0566251
In the Investigator’s opinion, is it safe for the subject to increase to the next dose level?
Description

Y - Subject will receive the next dose level. N - Select a dosing strategy from the options below and tick the relevant box:

Data type

boolean

Alias
UMLS CUI [1,1]
C1735338
UMLS CUI [1,2]
C1113679
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
Description

If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:

Data type

integer

Alias
UMLS CUI [1,1]
C1735338
UMLS CUI [1,2]
C1113679
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0679199
Dose Details
Description

Dose Details

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1522508
Dose to be attempted:
Description

Dose to be attempted:

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose Level Attempt:
Description

Dose Level Attempt:

Data type

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0441889
Dose Details - Comments
Description

Dose Details - Comments

Data type

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0947611
Dose checked and administered by:
Description

Dose checked and administered by:

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2348343
Dose checked and witnessed by:
Description

Dose checked and witnessed by:

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0682356
UMLS CUI [1,4]
C0178602
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Similar models

Drug Tolerance; Dose Details

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Drug Tolerance
C0013220 (UMLS CUI-1)
Did the patient tolerate 0.125mg/0.25mg?
Item
Did the patient tolerate 0.125mg/0.25mg?
boolean
C0013220 (UMLS CUI [1])
If patient did not tolerate the dose, enter the reason why
Item
If patient did not tolerate the dose, enter the reason why
text
C0013220 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
In the Investigator’s opinion, is it safe for the subject to increase to the next dose level?
Item
In the Investigator’s opinion, is it safe for the subject to increase to the next dose level?
boolean
C1735338 (UMLS CUI [1,1])
C1113679 (UMLS CUI [1,2])
Item
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
integer
C1735338 (UMLS CUI [1,1])
C1113679 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0679199 (UMLS CUI [2,2])
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
Code List
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
CL Item
Dose reduce to the dose level below (return to the previous dose level) for a further 1-4 days of dosing at the (1)
CL Item
lower dose level. (2)
CL Item
Administer domperidone to reduce adverse events. ONLY IF THIS IS A SECOND ATTEMPT AT THIS DOSE (3)
CL Item
LEVEL. (4)
CL Item
The investigator decides that the subject has reached their MTD. (5)
Item Group
Dose Details
C0678766 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Dose to be attempted:
Item
Dose to be attempted:
integer
C3174092 (UMLS CUI [1])
Dose Level Attempt:
Item
Dose Level Attempt:
integer
C3174092 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
Dose Details - Comments
Item
Dose Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose checked and administered by:
Item
Dose checked and administered by:
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [1,3])
Dose checked and witnessed by:
Item
Dose checked and witnessed by:
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
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