ID

44519

Descrição

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

Palavras-chave

Versões (3)
  1. 19/05/2020 19/05/2020 -
  2. 20/05/2020 20/05/2020 -
  3. 27/09/2021 27/09/2021 -
Titular dos direitos

GlaxoSmithKline

Transferido a

27 de setembro de 2021

DOI

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Licença

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

Inglês

Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms

1 Formulários  
Administrative
Descrição

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Pharmacogenetic Research
Descrição

Pharmacogenetic Research

Alias
UMLS CUI-1
C0031325
Has informed consent been obtained for Pharmacogenetic Research?
Descrição

Has informed consent been obtained for Pharmacogenetic Research?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If informed consent has been obtained for Pharmacogenetic Research, record date
Descrição

If informed consent has been obtained for Pharmacogenetic Research, record date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
Descrição

If informed consent has not been obtained for Pharmacogenetic Research, check one reason

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
Descrição

If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Has a blood sample been collected for Pharmacogenetic Research?
Descrição

Has a blood sample been collected for Pharmacogenetic Research?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
If a blood sample has been collected for Pharmacogenetic Research, record date
Descrição

If a blood sample has been collected for Pharmacogenetic Research, record date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Has this subject withdrawn consent for Pharmacogenetic Research?
Descrição

Has this subject withdrawn consent for Pharmacogenetic Research?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Has a request been made for sample destruction?
Descrição

Has a request been made for sample destruction?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If a request has been made for sample destruction, check one reason
Descrição

If a request has been made for sample destruction, check one reason

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0566251
If other reason for request for sample destruction, specify
Descrição

If other reason for request for sample destruction, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0566251
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Prior Medication
Descrição

Prior Medication

Alias
UMLS CUI-1
C2826257
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Descrição

Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205435
Prior Medication
Descrição

Prior Medication

Alias
UMLS CUI-1
C2826257
Drug Name
Descrição

Trade Name preferred

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
SINGLE Dose/ Unit
Descrição

e.g. 500 mg

Tipo de dados

text

Alias
UMLS CUI [1]
C1960417
Medication Frequency
Descrição

(e.g.BID,PRN)

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Descrição

Medication Route

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Medication Indication
Descrição

Medication Indication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Duration of Therapy
Descrição

eg.6 years

Tipo de dados

text

Alias
UMLS CUI [1]
C0444921
Medication End Date
Descrição

Medication End Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication continuing at end of study?
Descrição

Medication continuing at end of study?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1553904
Baseline Signs and Symptoms
Descrição

Baseline Signs and Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Baseline Sign/ Symptom
Descrição

Baseline Sign/ Symptom

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
Signs/ Symptoms Onset Date and Time
Descrição

Signs/ Symptoms Onset Date and Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C0449244
Signs/ Symptoms End Date and Time
Descrição

(If ongoing please leave blank)

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Signs/ Symptoms Outcome
Descrição

Signs/ Symptoms Outcome

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1547647
Signs/ Symptoms Event Course
Descrição

Signs/ Symptoms Event Course

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0441471
If intermittent Course, record number of episodes
Descrição

If intermittent Course, record number of episodes

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0205267
UMLS CUI [1,3]
C4086638
Signs/ Symmptoms Intensity
Descrição

maximum

Tipo de dados

integer

Alias
UMLS CUI [1]
C0518690
Relationship to study procedures performed prior to randomisation
Descrição

Relationship to study procedures performed prior to randomisation

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2700391
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0034656
Signs/ Symptoms Corrective Therapy
Descrição

Signs/ Symptoms Corrective Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this event?
Descrição

Was subject withdrawn due to this event?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Baseline Signs and Symptoms - Investigator's Signature
Descrição

Baseline Signs and Symptoms - Investigator's Signature

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
UMLS CUI-3
C2346576
Investigator's Signature
Descrição

Investigator's Signature

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Descrição

Investigator's Signature Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Pharmacogenetic Research
C0031325 (UMLS CUI-1)
Has informed consent been obtained for Pharmacogenetic Research?
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
If informed consent has been obtained for Pharmacogenetic Research, record date
Item
If informed consent has been obtained for Pharmacogenetic Research, record date
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
If informed consent been obtained for Pharmacogenetic Research has not been obtained, check one reason
Code List
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
Item
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Has a blood sample been collected for Pharmacogenetic Research?
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
If a blood sample has been collected for Pharmacogenetic Research, record date
Item
If a blood sample has been collected for Pharmacogenetic Research, record date
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has this subject withdrawn consent for Pharmacogenetic Research?
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check one reason
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
If a request has been made for sample destruction, check one reasen
Code List
If a request has been made for sample destruction, check one reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
If other reason for request for sample destruction, specify
Item
If other reason for request for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C2826257 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
SINGLE Dose/ Unit
Item
SINGLE Dose/ Unit
text
C1960417 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
inhalation (IH)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
nasal (NA)
CL Item
oral (PO)
CL Item
rectal (PR)
CL Item
subcutaneous (SC)
CL Item
sublingual (SL)
CL Item
transdermal (TD)
CL Item
topical (TO)
CL Item
vaginal (VA)
Medication Indication
Item
Medication Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Duration of Therapy
Item
Duration of Therapy
text
C0444921 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing at end of study?
Item
Medication continuing at end of study?
boolean
C1553904 (UMLS CUI [1])
Item Group
Baseline Signs and Symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Baseline Sign/ Symptom
Item
Baseline Sign/ Symptom
text
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Signs/ Symptoms Onset Date and Time
Item
Signs/ Symptoms Onset Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Signs/ Symptoms End Date and Time
Item
Signs/ Symptoms End Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Signs/ Symptoms Outcome
integer
C0037088 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Signs/ Symptoms Outcome
Code List
Signs/ Symptoms Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Signs/ Symptoms Event Course
integer
C0037088 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
Signs/ Symptoms Event Course
Code List
Signs/ Symptoms Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
If intermittent Course, record number of episodes
Item
If intermittent Course, record number of episodes
integer
C0750729 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Item
Signs/ Symmptoms Intensity
integer
C0518690 (UMLS CUI [1])
Signs/ Symmptoms Intensity
Code List
Signs/ Symmptoms Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomisation
integer
C2700391 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Relationship to study procedures performed prior to randomisation
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (3)
CL Item
Probable (4)
Signs/ Symptoms Corrective Therapy
Item
Signs/ Symptoms Corrective Therapy
boolean
C0037088 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was subject withdrawn due to this event?
Item
Was subject withdrawn due to this event?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Baseline Signs and Symptoms - Investigator's Signature
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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