ID

30487

Description

This ODM file contains Vital Signs. To be filled on Screening, Session 1 + 2 (one half Day -1, one half Day 1), Early Withdrawal and Follow-Up. 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

Vital Signs (All Visits)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Type
Description

This form has to be filled in at each attended visit mentioned in this item. On Session Visits the Body Measure Part is filled in on Day -1, the Rest on Day 1 (multiple time points).

Data type

text

Alias
UMLS CUI [1]
C0545082
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital Signs - Body Measures
Description

Vital Signs - Body Measures

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0203910
Height
Description

Only mandatory at screening visit.

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

Only mandatory at screening visit.

Data type

float

Measurement units
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Hip Circumference
Description

Hip Circumference

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0562350
cm
Waist Circumference
Description

Waist Circumference

Data type

float

Alias
UMLS CUI [1]
C0455829
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

On Session Visits not identical with date stated in administrative part of this form.

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Planned relative Time
Description

Planned relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Description

For each scheduled Planned Relative Time the measurements should first be done in semi-supine (4), then in standing (3) position.

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of Temperature Measurement
Description

Location of Temperature Measurement

Data type

integer

Alias
UMLS CUI [1]
C0489453
Respiration rate
Description

Respiration rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
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Similar models

Vital Signs (All Visits)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Visit
Code List
Visit Type
CL Item
Screening (Screening)
CL Item
Session 1 (Session 1)
CL Item
Session 2 (Session 2)
CL Item
Early Withdrawal (Early Withdrawal)
CL Item
Follow-Up (Follow-Up)
CL Item
Unscheduled (Unscheduled)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs - Body Measures
C0518766 (UMLS CUI-1)
C0203910 (UMLS CUI-2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Hip Circumference
Item
Hip Circumference
integer
C0562350 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C0455829 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date of Measurement
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned relative Time
Code List
Planned relative Time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
CL Item
Pre-dose (Sessions Day 1) (Pre-dose (Sessions Day 1))
CL Item
0,5 hrs (Sessions Day 1) (0,5 hrs (Sessions Day 1))
CL Item
2 hrs (Sessions Day 1) (2 hrs (Sessions Day 1))
CL Item
5 hrs (Sessions Day 1) (5 hrs (Sessions Day 1))
CL Item
6 hrs (Sessions Day 1) (6 hrs (Sessions Day 1))
CL Item
8 hrs (Sessions Day 1) (8 hrs (Sessions Day 1))
CL Item
12 hrs (Sessions Day 1) (12 hrs (Sessions Day 1))
CL Item
24 hrs (Sessions Day 1) (24 hrs (Sessions Day 1))
CL Item
Early Withdrawal (Early Withdrawal)
CL Item
Follow-Up (Follow-Up)
Actual Time
Item
Actual Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
integer
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
standing (3)
CL Item
semi-supine (4)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of Temperature Measurement
integer
C0489453 (UMLS CUI [1])
Location of Temperature Measurement
Code List
Location of Temperature Measurement
CL Item
oral (1)
CL Item
rectal (2)
CL Item
axilla (3)
CL Item
tympanic (4)
CL Item
intra-arterial (5)
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
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