ID

33649

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 response of the subjects general practicioner. It should be filled out at the first treatment period. Only include this form if a recent GP response is required before dosing. 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

  1. 18/12/2018 18/12/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

18 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 Study-ID 107434

  1. StudyEvent: ODM
    1. GP Response
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
Date Information Collected
Descrição

Date Information Collected

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
GP Response
Descrição

GP Response

Alias
UMLS CUI-1
C0017319
UMLS CUI-2
C1706817
Has the Principal Investigator (or delegate) reviewed a recent* response from the subject’s primary Physician?
Descrição

*Recent = dated within 12 months of the first dose administration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0017319
UMLS CUI [1,3]
C1706817
Is the subject suitable for study participation?
Descrição

If no, exclude

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3900053
Comments
Descrição

Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Descrição

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's Initials
Descrição

Physician's Initials

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Date
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008

Similar models

GP Response

  1. StudyEvent: ODM
    1. GP Response
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])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
GP Response
C0017319 (UMLS CUI-1)
C1706817 (UMLS CUI-2)
Recent Response from GP
Item
Has the Principal Investigator (or delegate) reviewed a recent* response from the subject’s primary Physician?
boolean
C0332185 (UMLS CUI [1,1])
C0017319 (UMLS CUI [1,2])
C1706817 (UMLS CUI [1,3])
Subject Suitable for Study Participation
Item
Is the subject suitable for study participation?
boolean
C2348568 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])

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