ID

30852

Description

This ODM file contains Documentation of Meals. To be filled at Sessions 1 and 2 (Several Timepoints each). 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. 6/27/18 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

Meal Documentation (Sessions 1 and 2)

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Type of Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Meal
Description

Meal

Alias
UMLS CUI-1
C1998602
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1998602
Date of randomisation
Description

Date of randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Planned relative Time
Description

Planned relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C1998602
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1998602
Stop Date
Description

Usually same as Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1998602
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1998602
Meal Type
Description

Meal Type

Data type

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0332307
Percent of meal completed
Description

Percent of Meal Completed

Data type

integer

Alias
UMLS CUI [1,1]
C0439165
UMLS CUI [1,2]
C1998602

Similar models

Meal Documentation (Sessions 1 and 2)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
Type of Visit
text
C0545082 (UMLS CUI [1])
Code List
Type of Visit
CL Item
Session 1 (Session 1)
CL Item
Session 2 (Session 2)
Item Group
Meal
C1998602 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned relative Time
text
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,3])
Code List
Planned relative Time
CL Item
Day -1 (Day -1)
CL Item
5 hrs post-dose (5 hrs)
CL Item
8 hrs post-dose (8 hrs)
CL Item
10 hrs post-dose (10 hrs)
CL Item
24 hrs post-dose (24 hrs)
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Item
Meal Type
text
C1998602 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Meal Type
CL Item
Breakfast (Breakfast)
CL Item
Lunch (Lunch)
CL Item
Dinner (Dinner)
CL Item
Snack (Snack)
Item
Percent of meal completed
integer
C0439165 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Code List
Percent of meal completed
CL Item
0% (0)
CL Item
1-25% (1)
CL Item
26-50% (2)
CL Item
51-75% (3)
CL Item
76-100% (4)

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