ID

33967

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2018-12-03 2018-12-03 -
  2. 2018-12-18 2018-12-18 -
  3. 2019-01-09 2019-01-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 januari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Engelsk

Eligibility Review on Admission

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

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

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Study Visit
Beskrivning

Study Visit

Datatyp

text

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

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?
Beskrivning

If No, please give the reason below

Datatyp

boolean

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

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

Datatyp

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?
Beskrivning

Sponsor contacted about Eligibility

Datatyp

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
Beskrivning

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

Datatyp

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?
Beskrivning

Proceed Dosage

Datatyp

boolean

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

Comment if the subject will not proceed to dosing?

Datatyp

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
Beskrivning

Eligibility Review

Datatyp

date

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

Physician's Initials

Datatyp

text

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

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
Beskrivning

Informed Consent Obtained

Datatyp

boolean

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

Informed Consent Date

Datatyp

date

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

Physician's Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Tillbaka till toppen

Similar models

Eligibility Review on Admission

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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