ID

33162

Beschreibung

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains: 1)alcohol intake form. It has to be filled in for screening. 2)alcohol breath test form. It has to be filled in for screening and study visit. 3) drug screen form. It has to be filled in for screening and study visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Stichworte

Versionen (2)
  1. 28.11.18 28.11.18 -
  2. 30.11.18 30.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30. November 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Englisch

Alcohol test, drug screen

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Beschreibung

Visit Description

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
ALCOHOL INTAKE
Beschreibung

ALCOHOL INTAKE

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beschreibung

Only for screening.

Datentyp

text

Alias
UMLS CUI [1]
C0001948
If subject consume alcohol, record the average number of units of alcohol consumed per week
Beschreibung

ALCOHOL CONVERTER: 1 unit of alcohol in UK = 1 measure of spirits, 1/2 pint beer, 1 small glass of wine (125ml) See facing page for conversion guidelines.

Datentyp

float

Maßeinheiten
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
ALCOHOL BREATH TEST
Beschreibung

ALCOHOL BREATH TEST

Alias
UMLS CUI-1
C0202306
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Results of sample
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0456984
DRUG SCREEN
Beschreibung

DRUG SCREEN

Alias
UMLS CUI-1
C0373483
Date of sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Time of sample taken
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Drugs
Beschreibung

Tick appropriate box(es). Note for each drug the result.

Datentyp

text

Alias
UMLS CUI [1]
C0033978
Drug result
Beschreibung

Note for each drug the result. If any of the drugs are positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C1274040
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Ähnliche Modelle

Alcohol test, drug screen

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item
Visit Description
integer
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Visit Description
Code List
Visit Description
CL Item
Screening (1)
CL Item
Study visit (2)
Item Group
ALCOHOL INTAKE
C0001948 (UMLS CUI-1)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Alcohol consumption
Code List
Does the subject consume alcohol?
CL Item
Yes (Y)
CL Item
No (N)
Alcohol consumption, units per week
Item
If subject consume alcohol, record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
ALCOHOL BREATH TEST
C0202306 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Results of sample
text
C0456984 (UMLS CUI [1])
Results of sample
Code List
Results of sample
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
DRUG SCREEN
C0373483 (UMLS CUI-1)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Time of sample taken
Item
Time of sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Drugs
text
C0033978 (UMLS CUI [1])
Drugs
Code List
Drugs
CL Item
Cocaine (1)
CL Item
Amphetamines (2)
CL Item
Benzodiazepines (3)
CL Item
Cannabinoids (4)
CL Item
Opiates (5)
CL Item
Barbiturates (6)
CL Item
Methadone (7)
CL Item
Cotinine (8)
Item
Drug result
text
C0033978 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Drug result
Code List
Drug result
CL Item
Positive (P)
CL Item
Negative (N)
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