ID
33432
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 This form contains informations about the subjects alcohol and tobacco use. 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
Stichworte
Versionen (4)
- 01.12.18 01.12.18 -
- 08.12.18 08.12.18 -
- 08.12.18 08.12.18 -
- 25.12.18 25.12.18 -
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
Alcohol and Tobacco Use
- StudyEvent: ODM
Beschreibung
Tobacco Use
Alias
- UMLS CUI-1
- C0040329
Beschreibung
Tobacco/Nicotine containing products
Datentyp
text
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
If former smoker
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0425310
- UMLS CUI [1,2]
- C0806020
Beschreibung
Exclude if current smoker smokes more than 10 cigarettes a day
Datentyp
integer
Alias
- UMLS CUI [1]
- C1608325
Beschreibung
If current smoker
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0337665
- UMLS CUI [1,2]
- C1608325
Beschreibung
If current smoker
Datentyp
integer
Maßeinheiten
- g
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C1265611
Beschreibung
If current smoker
Datentyp
text
Alias
- UMLS CUI [1]
- C0205394
Beschreibung
Alcohol consumption
Alias
- UMLS CUI-1
- C0001948
Beschreibung
Subject alcohol consumption
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
EXCLUDE IF ALCOHOL CONSUMPTION IS GREATER THAN 21 UNITS PER WEEK OR AN AVERAGE DAILY INTAKE IS GREATER THAN 3 UNITS Key 1 unit = 125ml glass of wine = 25ml of spirits = 220ml of beer
Datentyp
integer
Maßeinheiten
- Units/week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschreibung
Conclusion
Alias
- UMLS CUI-1
- C1707478
Ähnliche Modelle
Alcohol and Tobacco Use
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1608325 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])