ID
33425
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 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
Stichworte
Versionen (2)
- 01.12.18 01.12.18 -
- 08.12.18 08.12.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. Dezember 2018
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
Subject Screening Checklist
- StudyEvent: ODM
Beschreibung
General Information
Alias
- UMLS CUI-1
- C1508263
Beschreibung
ID Type
Datentyp
text
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Date of last Trial
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2348568
Beschreibung
If yes, please EXCLUDE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Beschreibung
GP Address, Fax and Tel.
Datentyp
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
Beschreibung
GP Disclosure
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C0012625
Beschreibung
GP Letter
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C1096774
Beschreibung
GP response
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0017319
- UMLS CUI [1,2]
- C1706817
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0281974
- UMLS CUI [1,2]
- C0021430
Beschreibung
Screening part only
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0742766
- UMLS CUI [1,3]
- C0031831
Beschreibung
Study Informed Consent Signed by Subject
Datentyp
text
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
HIV Consent
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019682
- UMLS CUI [1,2]
- C0021430
Beschreibung
Pharmacogenetic Consent
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031325
- UMLS CUI [1,2]
- C0021430
Beschreibung
Screening Talk
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0220908
- UMLS CUI [1,2]
- C0871703
Beschreibung
Clinical Assessments
Alias
- UMLS CUI-1
- C0220825
Beschreibung
Height, Weight
Datentyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0005910
Beschreibung
BMI
Datentyp
text
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Semi-Supine Vitals (BP and HR)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [2,1]
- C0522019
- UMLS CUI [2,2]
- C0005823
Beschreibung
Medical, Medication History and History
Datentyp
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0013227
- UMLS CUI [3]
- C0031809
Beschreibung
12-Lead ECG
Datentyp
text
Alias
- UMLS CUI [1]
- C0430456
Beschreibung
TMS
Datentyp
text
Alias
- UMLS CUI [1]
- C0436548
Beschreibung
EEG with Photostimulation
Datentyp
text
Alias
- UMLS CUI [1]
- C0430786
Beschreibung
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschreibung
4.5ml EDTA
Datentyp
text
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
6ml SST
Datentyp
text
Alias
- UMLS CUI [1]
- C0008000
Beschreibung
6ml SST
Datentyp
text
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Beschreibung
Urinalysis
Datentyp
text
Alias
- UMLS CUI [1]
- C0042014
Beschreibung
Urine Microscopy
Datentyp
text
Alias
- UMLS CUI [1]
- C0430397
Beschreibung
Drugs of Abuse and Alcohol Screen
Datentyp
text
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Beschreibung
Conclusion
Alias
- UMLS CUI-1
- C1707478
Beschreibung
Reason Subject is Ineligble
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2828389
Beschreibung
Clinical QC Initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034378
- UMLS CUI [1,2]
- C2986440
Beschreibung
CRM QC Initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0034378
- UMLS CUI [2]
- C3846158
Ähnliche Modelle
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])