ID

30488

Description

This ODM file contains Medical Conditions, alcohol intake and History of Tobacco use. To be filled in at screening visit (Date on Administrative Data, Demography and Child-Bearing Potential Form). 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
Copyright Holder

GlaxoSmithKline

Uploaded on

June 8, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


No comments

In order to download data models you must be logged in. Please log in or register for free.

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

Medical Conditions, Alcohol Intake and History of Tobacco Use

Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0262926
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines Use a new entry for each entity.

Data type

text

Alias
UMLS CUI [1]
C0011900
Current or Past
Description

CURRENT MEDICAL CONDITIONS: Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS: Conditions from which the subject has suffered in the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.

Data type

integer

Alias
UMLS CUI [1,1]
C1444635
UMLS CUI [1,2]
C0012634
Alcohol intake
Description

Alcohol intake

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

Alcohol consumption

Data type

text

Alias
UMLS CUI [1]
C0001948
If yes, record the average number of units of alcohol consumed per week.
Description

1 unit of alcohol in UK = half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.

Data type

float

Measurement units
  • units / week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units / week
History of Tobacco Use
Description

History of Tobacco Use

Alias
UMLS CUI-1
C0543414
What is the subject's history of smoking use?
Description

Never smoked: Never smoked Current smoker: Exclude current smokers as determined by urinary cotinine levels indicative of smoking Former smoker: Exclude subjects if there is a history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening

Data type

integer

Alias
UMLS CUI [1]
C1519384
If former smoker: When did the subject last smoke?
Description

Last smoking

Data type

date

Alias
UMLS CUI [1,1]
C0425310
UMLS CUI [1,2]
C0806020

Similar models

Medical Conditions, Alcohol Intake and History of Tobacco Use

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical Conditions
C0262926 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Current or Past
integer
C1444635 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Code List
Current or Past
CL Item
Current (1)
CL Item
Past (2)
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Code List
Does the subject consume alcohol?
CL Item
Yes (Y)
CL Item
No (N)
Units of alcohol per week
Item
If yes, record the average number of units of alcohol consumed per week.
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
History of Tobacco Use
C0543414 (UMLS CUI-1)
Item
What is the subject's history of smoking use?
integer
C1519384 (UMLS CUI [1])
Code List
What is the subject's history of smoking use?
CL Item
Never Smoked (1)
CL Item
Current Smoker (2)
CL Item
Former Smoker (3)
Last smoking
Item
If former smoker: When did the subject last smoke?
date
C0425310 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial