ID

30858

Description

This ODM file contains Pharmacogenetic (PGx) Research Information. 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

Versions (1)
  1. 6/27/18 6/27/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 27, 2018

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

English

Pharmacogenetic Research (PGx)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Consent for PGx Research (DNA)
Description

Consent for PGx Research (DNA)

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx research?
Description

Consent for Pharmacogenetic Research

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If Yes, record the date informed consent obtained for PGx research
Description

Date of consent for Pharmacogenetic Research

Data type

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If No, pick one reason:
Description

Reason no consent for Pharmacogenetic research

Data type

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Other Reason for no consent for PGx research, specify
Description

Other Reason no consent for Pharmacogenetic research

Data type

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
Sample Collection
Description

Sample Collection

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031325
Has a sample been collected for PGx research?
Description

Sample for Pharmacogenetic research

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
If Yes, record the date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0031325
Withdrawal of consent
Description

Withdrawal of consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Description

Withdrawal of consent for pharmacogenetic research

Data type

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
If Yes, record the date informed consent withdrawn for PGx research
Description

Date of consent withdrawal

Data type

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0031325
Sample Destruction
Description

Sample Destruction

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0178913
UMLS CUI-3
C0031325
Has a request been made for sample destruction?
Description

Request for sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
UMLS CUI [1,4]
C0031325
If Yes, pick one reason:
Description

Reason for sample destruction request

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
UMLS CUI [1,5]
C0031325
Other reason, specify
Description

Other Reason for sample destruction request

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
UMLS CUI [1,5]
C0031325
UMLS CUI [1,6]
C0205394
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Similar models

Pharmacogenetic Research (PGx)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit
Code List
Subject Identifier
Item Group
Consent for PGx Research (DNA)
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Relative Time
Code List
Has informed consent been obtained for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of consent for Pharmacogenetic Research
Item
If Yes, record the date informed consent obtained for PGx research
date
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If No, pick one reason:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason no consent for Pharmacogenetic research
Code List
If No, pick one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other (Z)
Other Reason no consent for Pharmacogenetic research
Item
Other Reason for no consent for PGx research, specify
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Sample Collection
C0005834 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Item
Has a sample been collected for PGx research?
text
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Sample for Pharmacogenetic research
Code List
Has a sample been collected for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date sample taken
Item
If Yes, record the date sample taken
date
C1302413 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Item Group
Withdrawal of consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Item
Has subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Relative Time
Code List
Has subject withdrawn consent for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of consent withdrawal
Item
If Yes, record the date informed consent withdrawn for PGx research
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Item Group
Sample Destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0031325 (UMLS CUI-3)
Item
Has a request been made for sample destruction?
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0031325 (UMLS CUI [1,4])
Relative Time
Code List
Has a request been made for sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, pick one reason:
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
C0031325 (UMLS CUI [1,5])
Reason for sample destruction request
Code List
If Yes, pick one reason:
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other (Z)
Item
Other reason, specify
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
C0031325 (UMLS CUI [1,5])
C0205394 (UMLS CUI [1,6])
Reason for sample destruction request
Code List
Other reason, specify
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