ID

33255

Descrição

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains informations about the subjects eligibility. It should be filled out at each treatment period. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Palavras-chave

Versões (3)
  1. 03/12/2018 03/12/2018 -
  2. 18/12/2018 18/12/2018 -
  3. 09/01/2019 09/01/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

3 de dezembro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold

Inglês

Eligibility Review on Admission

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Descrição

Subject Screening No.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Review on Admission
Descrição

Eligibility Review on Admission

Alias
UMLS CUI-1
C0013893
UMLS CUI-2
C0030673
Does the subject satisfy the inclusion/exclusion criteria of this study protocol?
Descrição

If No, please give the reason below

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1512693
Comment if the subject does not satisfy the inclusion/exclusion criteria of this study protocol.
Descrição

Inclusion/Exclusion Criteria Comment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1512693
Was the sponsor contacted about the subject’s eligibility?
Descrição

Sponsor contacted about Eligibility

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C2347796
UMLS CUI [1,3]
C0013893
Comment if the sponsor was contacted about the subject’s eligibility
Descrição

Sponsor contacted about Eligibility Comment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C2347796
UMLS CUI [1,3]
C0013893
Will the subject proceed to dosing?
Descrição

Proceed Dosage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0549178
Comment if the subject will not proceed to dosing?
Descrição

Proceed Dosage Comment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0947611
Date of Eligibility Review
Descrição

Eligibility Review

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013893
Informed Consent
Descrição

Informed Consent

Alias
UMLS CUI-1
C0021430
I confirm that the correct version of the study specific Informed Consent document has been signed and dated by the subject
Descrição

Informed Consent Obtained

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Date consent for study participation signed
Descrição

Informed Consent Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Conclusion
Descrição

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Descrição

Staff initials

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Eligibility Review on Admission

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Review on Admission
C0013893 (UMLS CUI-1)
C0030673 (UMLS CUI-2)
Inclusion/Exclusion Criteria
Item
Does the subject satisfy the inclusion/exclusion criteria of this study protocol?
boolean
C0680251 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Inclusion/Exclusion Criteria Comment
Item
Comment if the subject does not satisfy the inclusion/exclusion criteria of this study protocol.
text
C0680251 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Sponsor contacted about Eligibility
Item
Was the sponsor contacted about the subject’s eligibility?
boolean
C0332158 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,3])
Sponsor contacted about Eligibility Comment
Item
Comment if the sponsor was contacted about the subject’s eligibility
text
C0332158 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,3])
Proceed Dosage
Item
Will the subject proceed to dosing?
boolean
C0178602 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Proceed Dosage Comment
Item
Comment if the subject will not proceed to dosing?
boolean
C0178602 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Eligibility Review
Item
Date of Eligibility Review
date
C0011008 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Obtained
Item
I confirm that the correct version of the study specific Informed Consent document has been signed and dated by the subject
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Date consent for study participation signed
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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