ID

30489

Description

This ODM file contains Physical Examination documentation. To be filled in at Screening, Early Withdrawal and Follow-Up Visits. 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. 6/8/18 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

Physical Examination (Screening, Early Withdrawal, Follow-Up)

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Type of Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Organ System examined
Description

Examine all mentioned systems. Breast may be left out.

Data type

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0031809
Finding in Examination
Description

Not Done only possible for the examination of Breasts.

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
If abnormal, describe concisely
Description

different findings should be separated by either a (;) or a (/)

Data type

text

Alias
UMLS CUI [1,1]
C2826279
UMLS CUI [1,2]
C0031809

Similar models

Physical Examination (Screening, Early Withdrawal, Follow-Up)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Type of Visit
text
C0545082 (UMLS CUI [1])
Code List
Type of Visit
CL Item
Screening (Screening)
CL Item
Early Withdrawal (Early Withdrawal)
CL Item
Follow-Up (Follow-Up)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Organ System examined
integer
C0460002 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Code List
Organ System examined
CL Item
Hair and Skin (1)
CL Item
Lymph Nodes (2)
CL Item
Eyes (3)
CL Item
Ears, Nose and Throat (4)
CL Item
Breasts (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular (7)
CL Item
Abdomen (8)
CL Item
Musculoskeletal (9)
CL Item
Neurological (10)
CL Item
Thyroid (11)
Item
Finding in Examination
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Code List
Finding in Examination
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Abnormal Finding
Item
If abnormal, describe concisely
text
C2826279 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])

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