ID
33425
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 Checklist for the first screening of the study subject. It should be filled out at the screening visit. Every item should be checked and staff initials should be filled in next to the item. 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 (2)
- 2018-12-01 2018-12-01 -
- 2018-12-08 2018-12-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 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
Subject Screening Checklist
- StudyEvent: ODM
Beskrivning
General Information
Alias
- UMLS CUI-1
- C1508263
Beskrivning
ID Type
Datatyp
text
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Date of last Trial
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2348568
Beskrivning
If yes, please EXCLUDE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Beskrivning
GP Address, Fax and Tel.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C1442065
- UMLS CUI [2,1]
- C0017319
- UMLS CUI [2,2]
- C1549619
- UMLS CUI [3,1]
- C0017319
- UMLS CUI [3,2]
- C1515258
Beskrivning
GP Disclosure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C0012625
Beskrivning
GP Letter
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C1096774
Beskrivning
GP response
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C1706817
Beskrivning
if applicable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0281974
- UMLS CUI [1,2]
- C0021430
Beskrivning
Screening part only
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0742766
- UMLS CUI [1,3]
- C0031831
Beskrivning
Study Informed Consent Signed by Subject
Datatyp
text
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
HIV Consent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019682
- UMLS CUI [1,2]
- C0021430
Beskrivning
Pharmacogenetic Consent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031325
- UMLS CUI [1,2]
- C0021430
Beskrivning
Screening Talk
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0220908
- UMLS CUI [1,2]
- C0871703
Beskrivning
Clinical Assessments
Alias
- UMLS CUI-1
- C0220825
Beskrivning
Height, Weight
Datatyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0005910
Beskrivning
BMI
Datatyp
text
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
Semi-Supine Vitals (BP and HR)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [2,1]
- C0522019
- UMLS CUI [2,2]
- C0005823
Beskrivning
Medical, Medication History and History
Datatyp
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0013227
- UMLS CUI [3]
- C0031809
Beskrivning
12-Lead ECG
Datatyp
text
Alias
- UMLS CUI [1]
- C0430456
Beskrivning
TMS
Datatyp
text
Alias
- UMLS CUI [1]
- C0436548
Beskrivning
EEG with Photostimulation
Datatyp
text
Alias
- UMLS CUI [1]
- C0430786
Beskrivning
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beskrivning
4.5ml EDTA
Datatyp
text
Alias
- UMLS CUI [1]
- C0018941
Beskrivning
6ml SST
Datatyp
text
Alias
- UMLS CUI [1]
- C0008000
Beskrivning
6ml SST
Datatyp
text
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Beskrivning
Urinalysis
Datatyp
text
Alias
- UMLS CUI [1]
- C0042014
Beskrivning
Urine Microscopy
Datatyp
text
Alias
- UMLS CUI [1]
- C0430397
Beskrivning
Drugs of Abuse and Alcohol Screen
Datatyp
text
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Beskrivning
Conclusion
Alias
- UMLS CUI-1
- C1707478
Beskrivning
Reason Subject is Ineligble
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2828389
Beskrivning
Clinical QC Initials
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034378
- UMLS CUI [1,2]
- C2986440
Beskrivning
CRM QC Initials
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0034378
- UMLS CUI [2]
- C3846158
Similar models
Subject Screening Checklist
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C1442065 (UMLS CUI [1,2])
C0017319 (UMLS CUI [2,1])
C1549619 (UMLS CUI [2,2])
C0017319 (UMLS CUI [3,1])
C1515258 (UMLS CUI [3,2])
C0012625 (UMLS CUI [1,2])
C1096774 (UMLS CUI [1,2])
C1706817 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0742766 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0871703 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2])
C0018810 (UMLS CUI [1,2])
C0522019 (UMLS CUI [2,1])
C0005823 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0085762 (UMLS CUI [2])
C2828389 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0034378 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])