ID

33451

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 miscellaneous information about the subject. It should be filled out at screening visit. 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 (4)
  1. 2018-12-01 2018-12-01 -
  2. 2018-12-09 2018-12-09 -
  3. 2018-12-09 2018-12-09 -
  4. 2018-12-18 2018-12-18 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 december 2018

DOI

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Licens

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

Engelsk

Miscellaneous Information

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
Date Information Collected
Beskrivning

Date Information Collected

Datatyp

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Miscellaneous Information
Beskrivning

Miscellaneous Information

Alias
UMLS CUI-1
C0205395
UMLS CUI-2
C1955348
Has the subject an adequate command of the English language (written and verbal)?
Beskrivning

Able to Read and Write English

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
Details If Not Able to Speak or Write English
Beskrivning

To be filled out if the subject has no adequate command of the English language

Datatyp

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0586740
UMLS CUI [1,4]
C0376245
UMLS CUI [2,1]
C1522508
UMLS CUI [2,2]
C1299582
UMLS CUI [2,3]
C0584993
UMLS CUI [2,4]
C0376245
Has the subject contracted any tropical diseases?
Beskrivning

Tropical Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1336827
Details if the subject contracted any tropical diseases, including dates if possible
Beskrivning

To be filled out if the subject contracted any tropical diseases

Datatyp

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1336827
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1336827
Has the subject travelled to tropical countries (other than country of origin)?
Beskrivning

Travels to Tropical Countries

Datatyp

boolean

Alias
UMLS CUI [1]
C2938902
If the subject has travelled to tropical countries, give details including dates if possible.
Beskrivning

Details to Travels to Tropical Countries

Datatyp

text

Alias
UMLS CUI [1,1]
C2938902
UMLS CUI [1,2]
C1522508
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C2938902
Conclusion
Beskrivning

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Physician's Initials
Beskrivning

Physician's Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Similar models

Miscellaneous Information

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])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Miscellaneous Information
C0205395 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
Able to Read and Write English
Item
Has the subject an adequate command of the English language (written and verbal)?
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Details If Not Able to Speak or Write English
Item
Details If Not Able to Speak or Write English
text
C1522508 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0586740 (UMLS CUI [1,3])
C0376245 (UMLS CUI [1,4])
C1522508 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0584993 (UMLS CUI [2,3])
C0376245 (UMLS CUI [2,4])
Tropical Diseases
Item
Has the subject contracted any tropical diseases?
boolean
C0262926 (UMLS CUI [1,1])
C1336827 (UMLS CUI [1,2])
Tropical Diseases
Item
Details if the subject contracted any tropical diseases, including dates if possible
text
C1522508 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1336827 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2,1])
C1336827 (UMLS CUI [2,2])
Travels to Tropical Countries
Item
Has the subject travelled to tropical countries (other than country of origin)?
boolean
C2938902 (UMLS CUI [1])
Details to Travels to Tropical Countries
Item
If the subject has travelled to tropical countries, give details including dates if possible.
text
C2938902 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C2938902 (UMLS CUI [2,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (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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