ID

33967

Beschreibung

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

Stichworte

Versionen (3)
  1. 03.12.18 03.12.18 -
  2. 18.12.18 18.12.18 -
  3. 09.01.19 09.01.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Januar 2019

DOI

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Lizenz

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

Englisch

Eligibility Review on Admission

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

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

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Study Visit
Beschreibung

Study Visit

Datentyp

text

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

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?
Beschreibung

If No, please give the reason below

Datentyp

boolean

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

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

Datentyp

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?
Beschreibung

Sponsor contacted about Eligibility

Datentyp

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
Beschreibung

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

Datentyp

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?
Beschreibung

Proceed Dosage

Datentyp

boolean

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

Comment if the subject will not proceed to dosing?

Datentyp

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
Beschreibung

Eligibility Review

Datentyp

date

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

Physician's Initials

Datentyp

text

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

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
Beschreibung

Informed Consent Obtained

Datentyp

boolean

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

Informed Consent Date

Datentyp

date

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

Physician's Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Review on Admission

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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