ID

30496

Description

This ODM file contains the Appetite VAS and Distress VAS. Appetite VAS to be done at Screening, Sessions 1 and 2 (Day 1, pre-dose and 2 hrs post-dose), Distress VAS to be done at Sessions 1 and 2 (Day 1, pre-dose, 2, 4 and 10 hrs post-dose). 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

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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

Appetite and Distress VAS (Screening, Sessions 1 and 2)

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
Type of Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Appetite VAS
Description

Appetite VAS

Alias
UMLS CUI-1
C0003618
UMLS CUI-2
C3536884
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C0003618
UMLS CUI [1,3]
C3536884
Relative Time on Session Visits
Description

Item not to be used at screening Visit.

Data type

text

Alias
UMLS CUI [1,1]
C0003618
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0439564
Time of Assessment
Description

Time of Assessment

Data type

time

Alias
UMLS CUI [1,1]
C0003618
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0040223
How hungry are you feeling?
Description

Result from the VAS: mm from left end of scale 0 mm -> not feeling any hunger 100 mm -> feeling the hungriest ever felt

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0849960
mm
How full do you feel?
Description

Result from the VAS: mm from left end of scale 0 mm -> Feeling very full 100 mm -> not feeling full at all

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C1286349
mm
How much do you crave fatty or sugary foods?
Description

Result from the VAS: mm from left end of scale 0 mm -> not craving those foods at all 100 mm -> craving those foods very much

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0241314
UMLS CUI [2,1]
C0872380
UMLS CUI [2,2]
C0453819
mm
Distress VAS
Description

Distress VAS

Alias
UMLS CUI-1
C3536884
UMLS CUI-2
C0231303
Date of Assessment
Description

Not neccessary on Screening visit.

Data type

date

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
UMLS CUI [1,3]
C2985720
Time of Assessment
Description

Not neccessary on Screening visit.

Data type

time

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1516048
Relative Time on Session Visits
Description

Not to be filled at screening visit.

Data type

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1516048
How distressed do you feel at the present time?
Description

VAS: Mark a single line that crosses at the point of the given line that represents how you feel at the present time. 0mm: No distress 100mm: Maximum distress Not neccessary on Screening visit.

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0231303
UMLS CUI [1,2]
C0441889
mm
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Similar models

Appetite and Distress VAS (Screening, Sessions 1 and 2)

1 forms
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])
Visit
Code List
Type of Visit
CL Item
Screening (Screening)
CL Item
Session 1 (Session 1)
CL Item
Session 2 (Session 2)
Item Group
Appetite VAS
C0003618 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1,1])
C0003618 (UMLS CUI [1,2])
C3536884 (UMLS CUI [1,3])
Item
Relative Time on Session Visits
text
C0003618 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
Relative Time of Assessment
Code List
Relative Time on Session Visits
CL Item
pre-dose (Day 1) (pre-dose (Day 1))
CL Item
2 hrs post-dose (Day 1) (2 hrs post-dose (Day 1))
Time of Assessment
Item
Time of Assessment
time
C0003618 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hungry
Item
How hungry are you feeling?
float
C0849960 (UMLS CUI [1])
Fullness
Item
How full do you feel?
float
C1286349 (UMLS CUI [1])
Craving for fatty or sugary foods
Item
How much do you crave fatty or sugary foods?
float
C0241314 (UMLS CUI [1])
C0872380 (UMLS CUI [2,1])
C0453819 (UMLS CUI [2,2])
Item Group
Distress VAS
C3536884 (UMLS CUI-1)
C0231303 (UMLS CUI-2)
Date of Assessment
Item
Date of Assessment
date
C3536884 (UMLS CUI [1,1])
C0231303 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Time of Assessment
Item
Time of Assessment
time
C3536884 (UMLS CUI [1,1])
C0231303 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
Item
Relative Time on Session Visits
text
C3536884 (UMLS CUI [1,1])
C0231303 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
Relative Time
Code List
Relative Time on Session Visits
CL Item
pre-dose (Day 1) (pre-dose (Day 1))
CL Item
2 hrs post-dose (Day 1) (2 hrs post-dose (Day 1))
CL Item
4 hrs post-dose (Day 1) (4 hrs post-dose (Day 1))
CL Item
10 hrs post-dose (Day 1) (10 hrs post-dose (Day 1))
Distress level
Item
How distressed do you feel at the present time?
float
C0231303 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
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