ID

44429

Description

This ODM file contains Alcohol Breath Test, Cotinine Screen and Drug Screening. To be filled in at Screening and Sessions 1 and 2 (Day -1). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

  1. 6/8/18 6/8/18 - Sarah Riepenhausen
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0

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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

Alcohol Breath Test, Cotinine and Drugs Screenings (Screening and Sessions Visits)

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Type of Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Alcohol Breath Test
Description

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Date Sample Taken
Description

Date Sample Taken

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0202306
Result
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1274040
Cotinine Screen
Description

Cotinine Screen

Alias
UMLS CUI-1
C0202363
Date and Time sample Taken
Description

Date and Time sample Taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0200345
Cotinine Finding
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0243095
Drug Screen
Description

Drug Screen

Alias
UMLS CUI-1
C0373483
Date and Time of Sample Taken
Description

Date and Time of Sample Taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0200345
Drug
Description

Drug

Data type

text

Alias
UMLS CUI [1]
C0086190
UMLS CUI [2]
C0013146
Result
Description

If any of the drugs mentioned are positive, exclude subject from study

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0373483

Similar models

Alcohol Breath Test, Cotinine and Drugs Screenings (Screening and Sessions Visits)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Type of Visit
text
C0545082 (UMLS CUI [1])
Code List
Type of Visit
CL Item
Screening (Screening)
CL Item
Session 1 (Day -1) (Session 1 (Day -1))
CL Item
Session 2 (Session 2)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1,1])
C0202306 (UMLS CUI [1,2])
Item
Result
text
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Result
CL Item
positive (positive)
CL Item
negative (negative)
Item Group
Cotinine Screen
C0202363 (UMLS CUI-1)
Date and Time sample Taken
Item
Date and Time sample Taken
datetime
C0202363 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
Cotinine Finding
text
C0202363 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Code List
Cotinine Finding
CL Item
positive (positive)
CL Item
negative (negative)
Item Group
Drug Screen
C0373483 (UMLS CUI-1)
Date and Time of Sample Taken
Item
Date and Time of Sample Taken
datetime
C0373483 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
Drug
text
C0086190 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Code List
Drug
CL Item
Cocaine (Cocaine)
CL Item
Aphetamines (Aphetamines)
CL Item
Benzodiazepines (Benzodiazepines)
CL Item
Cannabinoids (Cannabinoids)
CL Item
Opiates (Opiates)
CL Item
Barbiturates (Barbiturates)
CL Item
Methadone (Methadone)
Item
Result
text
C1274040 (UMLS CUI [1,1])
C0373483 (UMLS CUI [1,2])
Code List
Result
CL Item
positive (positive)
CL Item
negative (negative)

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