ID

30484

Description

This ODM file contains Administrative Data and Demography as well as Child-bearing Potential. To be filled at Screening Visit. 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. 6/8/18 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.

Back to model comments
Itemgroup comments for :

Item comments for :

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

English

Screening: Administrative Data, Demography, Child-bearing Potential

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Description

Volunteer Identifier

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0020155
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry: African American/African Heritage
Description

[1 1] A person having origins in any of the black racial groups of Africa

Data type

boolean

Alias
UMLS CUI [1]
C0085756
Geographic Ancestry: American Indian or Alaskan Native
Description

[1 2] A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Geographic Ancestry: Asian - Central/South Asian Heritage
Description

[1 3] A person having origins in Central Asia (Kazakstan, Kyrgystan, Tajikstan, Turkmenistan and Uzbekistan) and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Geographic Ancestry: Asian - East Asian Heritage
Description

[1 4] A person having origins in China, Korea

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Geographic Ancestry: Asian - Japanese Heritage
Description

[1 5] A person having origins in Japan

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Geographic Ancestry: Asian - South East Asian Heritage
Description

[1 6] A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Geographic Ancestry: bNative Hawaiian or Other Pacific Islander
Description

[1 7] A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines), Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan

Data type

boolean

Alias
UMLS CUI [1]
C1513907
Geographic Ancestry: White - Arabic/North African Heritage
Description

[1 8] A person having origins in any of the original peoples of Middle East or North Africa

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C1552588
Geographic Ancestry: White - White/Caucasian/European Heritage
Description

[1 9] A person having origins in any of the original peoples of Europe

Data type

boolean

Alias
UMLS CUI [1]
C0043157
Child-bearing Potential
Description

Child-bearing Potential

Alias
UMLS CUI-1
C3831118
Child-bearing Potenital
Description

Post-menopausal: Women who have completed menopause at least one year ago. Sterile: Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.) Note: If the subject is sterile and is not of child-bearing age, then ‘post-menopausal’ will be the best choice and should be picked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and ‘sterile’ should be picked. Potentially able to bear children: Women of child-bearing age who are not sterile. Note:

Data type

integer

Alias
UMLS CUI [1]
C3831118
Date of last menstrual period
Description

Date of last menstrual period

Data type

date

Alias
UMLS CUI [1]
C0425932
If sterile, date became sterile
Description

Date becoming sterile

Data type

date

Alias
UMLS CUI [1,1]
C0232920
UMLS CUI [1,2]
C0015787
UMLS CUI [2,1]
C0021359
UMLS CUI [2,2]
C0011008
Back to the top of the page

Similar models

Screening: Administrative Data, Demography, Child-bearing Potential

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
African American/African Heritage
Item
Geographic Ancestry: African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
American Indian or Alaskan Native
Item
Geographic Ancestry: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Central/South Asian Heritage
Item
Geographic Ancestry: Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
East Asian Heritage
Item
Geographic Ancestry: Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Japanese Heritage
Item
Geographic Ancestry: Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
South East Asian Heritage
Item
Geographic Ancestry: Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Geographic Ancestry: bNative Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Arabic/North African Heritage
Item
Geographic Ancestry: White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C1552588 (UMLS CUI [2])
White/Caucasian/European Heritage
Item
Geographic Ancestry: White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
Item Group
Child-bearing Potential
C3831118 (UMLS CUI-1)
Item
Child-bearing Potenital
integer
C3831118 (UMLS CUI [1])
Child-bearing Potenital
Code List
Child-bearing Potenital
CL Item
post-menopausal (2)
CL Item
sterile (of child-bearing age) (3)
CL Item
potentially able to bear children (4)
Date of last menstrual period
Item
Date of last menstrual period
date
C0425932 (UMLS CUI [1])
Date becoming sterile
Item
If sterile, date became sterile
date
C0232920 (UMLS CUI [1,1])
C0015787 (UMLS CUI [1,2])
C0021359 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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