ID
33200
Beschrijving
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. 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
Trefwoorden
Versies (2)
- 01-12-18 01-12-18 -
- 08-12-18 08-12-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 december 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Effect of Lamictal on Resting Motor Threshold
Subject Screening Checklist Effect of Lamictal on Resting Motor Threshold
Beschrijving
General Information
Alias
- UMLS CUI-1
- C1508263
Beschrijving
ID Type
Datatype
text
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Date of last Trial
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2347449
Beschrijving
If yes, please EXCLUDE
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Beschrijving
GP Address, Fax and Tel.
Datatype
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
Beschrijving
GP Disclosure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C0012625
Beschrijving
GP Letter
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C1096774
Beschrijving
GP response
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C1706817
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0281974
- UMLS CUI [1,2]
- C0021430
Beschrijving
Screening part only
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0742766
- UMLS CUI [1,3]
- C0031831
Beschrijving
Study Informed Consent Signed by Subject
Datatype
text
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
HIV Consent
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019682
- UMLS CUI [1,2]
- C0021430
Beschrijving
Pharmacogenetic Consent
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031325
- UMLS CUI [1,2]
- C0021430
Beschrijving
Screening Talk
Datatype
text
Alias
- UMLS CUI [1,1]
- C0220908
- UMLS CUI [1,2]
- C0871703
Beschrijving
Clinical Assessments
Alias
- UMLS CUI-1
- C0220825
Beschrijving
Height, Weight
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
Beschrijving
BMI
Datatype
text
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
Semi-Supine Vitals (BP and HR)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [2,1]
- C0522019
- UMLS CUI [2,2]
- C0005823
Beschrijving
Medical, Medication History and History
Datatype
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0013227
- UMLS CUI [3]
- C0031809
Beschrijving
12-Lead ECG
Datatype
text
Alias
- UMLS CUI [1]
- C0430456
Beschrijving
TMS
Datatype
text
Alias
- UMLS CUI [1]
- C0436548
Beschrijving
EEG with Photostimulation
Datatype
text
Alias
- UMLS CUI [1]
- C0430786
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
4.5ml EDTA
Datatype
text
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
6ml SST
Datatype
text
Alias
- UMLS CUI [1]
- C0008000
Beschrijving
6ml SST
Datatype
text
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Beschrijving
Urinalysis
Datatype
text
Alias
- UMLS CUI [1]
- C0042014
Beschrijving
Urine Microscopy
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0430397
Beschrijving
Drugs of Abuse and Alcohol Screen
Datatype
text
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Beschrijving
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Subject Screening Checklist Effect of Lamictal on Resting Motor Threshold
C1517741 (UMLS CUI [1,2])
C2347449 (UMLS CUI [1,3])
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 [1,2])
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])
C0430397 (UMLS CUI [1,2])
C0085762 (UMLS CUI [2])
C2828389 (UMLS CUI [1,2])