ID
39347
Beschreibung
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders
Stichworte
Versionen (1)
- 27.12.19 27.12.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27. Dezember 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586
Screen
- StudyEvent: ODM
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Patient date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnic group
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Your ancestry or national origin
Datentyp
text
Alias
- UMLS CUI [1]
- C3841890
Beschreibung
VS Semi-supine
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0522019
Beschreibung
Vital signs, Semi-erect, Date in time, Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body mass index
Datentyp
float
Maßeinheiten
- kg / m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Systolic Pressure, Semi-erect
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0522019
Beschreibung
Diastolic blood pressure, Semi-erect
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0522019
Beschreibung
Heart rate, Semi-erect
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0522019
Beschreibung
VS Standing
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0522014
Beschreibung
Vital signs, Erect, Date in time, Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522014
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body mass index
Datentyp
float
Maßeinheiten
- kg / m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Systolic Pressure, Erect
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0522014
Beschreibung
Diastolic blood pressure, Erect
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0522014
Beschreibung
Heart rate, Erect
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0522014
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
12 lead ECG, Date in time, Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschreibung
12 lead ECG, Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beschreibung
12 lead ECG, PR interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschreibung
12 lead ECG, QRS complex duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschreibung
12 lead ECG, QT Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschreibung
12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method
Datentyp
text
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
- UMLS CUI [1,3]
- C2911685
Beschreibung
12 lead ECG, Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschreibung
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Gender; Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Beschreibung
Childbearing Potential
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3831118
Beschreibung
Contraceptive methods
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
Health Status
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018759
Beschreibung
Body mass index; Body Weight
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1305855
- UMLS CUI [2]
- C0005910
Beschreibung
Informed Consent; Protocol Compliance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0525058
Beschreibung
English Language
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0376245
Beschreibung
Aspartate aminotransferase measurement; Alanine aminotransferase measurement; Alkaline phosphatase measurement; Bilirubin measurement
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0201899
- UMLS CUI [2]
- C0201836
- UMLS CUI [3]
- C0201850
- UMLS CUI [4]
- C0344395
Beschreibung
QTc interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Vital signs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518766
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Mental disorders
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004936
Beschreibung
At risk for suicide
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0563664
Beschreibung
Cardiovascular Diseases
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0007222
Beschreibung
Long QT Syndrome; Cardiac conduction abnormality; Heart Diseases
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023976
- UMLS CUI [2]
- C1842820
- UMLS CUI [3]
- C0018799
Beschreibung
Cerebrovascular Disorders
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0007820
Beschreibung
Autonomic nervous system, Dysfunction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0004388
- UMLS CUI [1,2]
- C3887504
Beschreibung
Respiration Disorders
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0035204
Beschreibung
Kidney Diseases
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0022658
Beschreibung
Laboratory Procedures, Renal function
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0232804
Beschreibung
Gastrointestinal Hemorrhage; Peptic Ulcer; Gastrointestinal Diseases, Active
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0017181
- UMLS CUI [2]
- C0030920
- UMLS CUI [3,1]
- C0017178
- UMLS CUI [3,2]
- C0205177
Beschreibung
Liver diseases; Abnormality of the liver; Biliary tract abnormality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023895
- UMLS CUI [2]
- C4021780
- UMLS CUI [3]
- C0549613
Beschreibung
Disease, Study Subject Participation Status
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348568
Beschreibung
Hepatitis B surface antigen positive; Hepatitis C antibody positive
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
Beschreibung
HIV antibody positive
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0920548
Beschreibung
Drug abuse; Alcohol abuse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Beschreibung
Drug screen (procedure); Blood alcohol test positive
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0373483
- UMLS CUI [2]
- C0948726
Beschreibung
Alcohol consumption
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Tobacco use
Datentyp
text
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
Pharmaceutical Preparations
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Red wine; Citrus aurantium; Grapefruit (food); GRAPEFRUIT JUICE
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0349371
- UMLS CUI [2]
- C0330922
- UMLS CUI [3]
- C0995150
- UMLS CUI [4]
- C0452456
Beschreibung
Experimental drug, Hypersensitivity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0020517
Beschreibung
Dextromethorphan, Hypersensitivity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011816
- UMLS CUI [1,2]
- C0020517
Beschreibung
Study Subject Participation Status
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Pharmaceutical Preparations, New
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0205314
Beschreibung
Blood Donation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005794
Beschreibung
Protocol Compliance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0525058
Beschreibung
Mental handicap; legal capacity, Lacking
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1306341
- UMLS CUI [2,1]
- C0683673
- UMLS CUI [2,2]
- C0332268
Beschreibung
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beschreibung
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschreibung
Randomization, Possible
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0332149
Beschreibung
Randomization, Numbers
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Randomization, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beschreibung
Holter
Alias
- UMLS CUI-1
- C0013801
Beschreibung
Holter Electrocardiography, Start Date, Start time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Beschreibung
Holter Electrocardiography, End Date, End Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Beschreibung
Holter Electrocardiography, Clinical Interpretation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C4086187
Beschreibung
Summary Holter Abnormalities
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C1704258
Beschreibung
Holter Electrocardiography, Abnormality
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1704258
Beschreibung
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Hematology finding, Sampling, Date in time, Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschreibung
Hematology finding, Sampling, Not Done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1272696
Beschreibung
Chemistry, Clinical, Sampling, Date in time, Time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschreibung
Chemistry, Clinical, Sampling, Date in time, Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschreibung
Chemistry, Clinical, Sampling, Not Done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1272696
Beschreibung
Urinalysis, Sampling, Date in time, Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschreibung
Urinalysis, Sampling, Not Done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1272696
Ähnliche Modelle
Screen
- StudyEvent: ODM
C2985720 (UMLS CUI [1,2])
C0599755 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0522014 (UMLS CUI [1,2])
C0522014 (UMLS CUI [1,2])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0005910 (UMLS CUI [2])
C0525058 (UMLS CUI [2])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0344395 (UMLS CUI [4])
C1842820 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C3887504 (UMLS CUI [1,2])
C0232804 (UMLS CUI [1,2])
C0030920 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C4021780 (UMLS CUI [2])
C0549613 (UMLS CUI [3])
C2348568 (UMLS CUI [1,2])
C0281863 (UMLS CUI [2])
C0085762 (UMLS CUI [2])
C0948726 (UMLS CUI [2])
C0330922 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
C0452456 (UMLS CUI [4])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0332149 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C4086187 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])