ID

33648

Beschrijving

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

Trefwoorden

Versies (3)
  1. 03-12-18 03-12-18 -
  2. 18-12-18 18-12-18 -
  3. 09-01-19 09-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Engels

Eligibility Review on Admission

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

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

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Study Visit
Beschrijving

Study Visit

Datatype

text

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

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?
Beschrijving

If No, please give the reason below

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1512693
Does the subject satisfy the inclusion/exclusion criteria of this study protocol?
Beschrijving

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

Datatype

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?
Beschrijving

Sponsor contacted about Eligibility

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C2347796
UMLS CUI [1,3]
C0013893
Was the sponsor contacted about the subject’s eligibility?
Beschrijving

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

Datatype

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?
Beschrijving

Proceed Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0549178
Will the subject proceed to dosing?
Beschrijving

Comment if the subject will not proceed to dosing?

Datatype

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
Beschrijving

Eligibility Review

Datatype

date

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

Physician's Initials

Datatype

text

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

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
Beschrijving

Informed Consent Obtained

Datatype

boolean

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

Informed Consent Date

Datatype

date

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

Physician's Initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschrijving

Staff initials

Datatype

text

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

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Eligibility Review on Admission

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Does the subject satisfy the inclusion/exclusion criteria of this study protocol?
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
Was the sponsor contacted about the subject’s eligibility?
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
Will the subject proceed to dosing?
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])
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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