ID

33255

Description

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

Keywords

Versions (3)
  1. 12/3/18 12/3/18 -
  2. 12/18/18 12/18/18 -
  3. 1/9/19 1/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 3, 2018

DOI

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License

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

English

Eligibility Review on Admission

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

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

Subject Number

Data type

integer

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

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?
Description

If No, please give the reason below

Data type

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.
Description

Inclusion/Exclusion Criteria Comment

Data type

text

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

Sponsor contacted about Eligibility

Data type

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
Description

Sponsor contacted about Eligibility Comment

Data type

text

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

Proceed Dosage

Data type

boolean

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

Proceed Dosage Comment

Data type

boolean

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

Eligibility Review

Data type

date

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

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
Description

Informed Consent Obtained

Data type

boolean

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

Informed Consent Date

Data type

date

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

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Description

Staff initials

Data type

text

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Eligibility Review on Admission

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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