ID

33765

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 the study conclusion.

Nyckelord

Versioner (2)
  1. 2018-12-05 2018-12-05 -
  2. 2018-12-25 2018-12-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 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

Study Conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Study Conclusion
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 Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Beskrivning

Date of Completion or Withdrawal

Datatyp

date

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C2349954
Time of Withdrawal
Beskrivning

Time of Withdrawal

Datatyp

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Beskrivning

If Yes, tick the primary reason for withdrawal

Datatyp

boolean

Alias
UMLS CUI [1]
C2349954
Reason for Withdrawal
Beskrivning

Tick primary reason for withdrawal If Adverse Event, record details on the Non-Serious Adverse Events or Serious Adverse Events pages

Datatyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
If other reason, specify
Beskrivning

Other Reason Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Did the subject become pregnant during the study?
Beskrivning

Pregnancy

Datatyp

text

Alias
UMLS CUI [1]
C0032961
Physician's Initials
Beskrivning

Physician's Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Additional Information
Beskrivning

Additional Information

Alias
UMLS CUI-1
C1546922
Is there any additional information to be added to the subject’s CRF?
Beskrivning

Additional Information

Datatyp

boolean

Alias
UMLS CUI [1]
C1546922
Comment Additional Information
Beskrivning

If Yes, provide details below

Datatyp

text

Alias
UMLS CUI [1,1]
C1546922
UMLS CUI [1,2]
C0947611
Physician's Initials
Beskrivning

Physician's Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Investigator Statement
Beskrivning

Investigator Statement

To the best of my knowledge, the data in this CRF have been entered or transcribed by trained and experienced staff, submitted to a full quality control and/or plausibility check, and are correct at the date of signing.
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Study Conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Study Conclusion
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 Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of Completion or Withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Time of Withdrawal
Item
Time of Withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1])
Item
Reason for Withdrawal
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for Withdrawal
Code List
Reason for Withdrawal
CL Item
Adverse Event (1)
CL Item
Lost to follow up (2)
CL Item
Protocol Violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated the study (5)
CL Item
Other (6)
Other Reason Specification
Item
If other reason, specify
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (not of childbearing potential or male) (X)
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item Group
Additional Information
C1546922 (UMLS CUI-1)
Additional Information
Item
Is there any additional information to be added to the subject’s CRF?
boolean
C1546922 (UMLS CUI [1])
Comment Additional Information
Item
Comment Additional Information
text
C1546922 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Investigator Statement
Signature
Item
To the best of my knowledge, the data in this CRF have been entered or transcribed by trained and experienced staff, submitted to a full quality control and/or plausibility check, and are correct at the date of signing.
text
C1519316 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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