ID

33967

Descripción

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

Palabras clave

Versiones (3)
  1. 3/12/18 3/12/18 -
  2. 18/12/18 18/12/18 -
  3. 9/1/19 9/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

Sin comentarios

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Inglés

Eligibility Review on Admission

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Descripción

Subject Screening No.

Tipo de datos

integer

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

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Study Visit
Descripción

Study Visit

Tipo de datos

text

Alias
UMLS CUI [1]
C0545082
Eligibility Review on Admission
Descripción

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?
Descripción

If No, please give the reason below

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1512693
If no, please give reason below.
Descripción

Comment if the subject does not satisfy the inclusion/exclusion criteria of this study protocol.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0947611
UMLS CUI [2,2]
C1512693
UMLS CUI [2,3]
C0231175
Was the sponsor contacted about the subject’s eligibility?
Descripción

Sponsor contacted about Eligibility

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C2347796
UMLS CUI [1,3]
C0013893
If Yes, please give details below and append the Sponsor’s reply to the CRF
Descripción

Comment if the sponsor was contacted about the subject’s eligibility

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C2347796
UMLS CUI [1,4]
C0013893
UMLS CUI [1,5]
C0231175
Will the subject proceed to dosing?
Descripción

Proceed Dosage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0549178
If No, give reason below
Descripción

Comment if the subject will not proceed to dosing?

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0947611
UMLS CUI [1,5]
C0231175
Date of Eligibility Review
Descripción

Eligibility Review

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013893
Physician's Initials
Descripción

Physician's Initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Informed Consent
Descripción

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
Descripción

Informed Consent Obtained

Tipo de datos

boolean

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

Informed Consent Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Physician's Initials
Descripción

Physician's Initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Volver a la parte superior de la página

Similar models

Eligibility Review on Admission

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
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])
C1512693 (UMLS CUI [2])
Inclusion/Exclusion Criteria Comment
Item
If no, please give reason below.
text
C0947611 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
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
If Yes, please give details below and append the Sponsor’s reply to the CRF
text
C0947611 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C0013893 (UMLS CUI [1,4])
C0231175 (UMLS CUI [1,5])
Proceed Dosage
Item
Will the subject proceed to dosing?
boolean
C0178602 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Proceed Dosage Comment
Item
If No, give reason below
text
C0947611 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0231175 (UMLS CUI [1,5])
Eligibility Review
Item
Date of Eligibility Review
date
C0011008 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (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])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial