ID

30548

Description

This ODM file contains Information about a Pregnancy Test and the last menstrual period. To be filled at Screening, Session 1 (Day -1), Session 2 (Day -1), Early Withdrawal and Follow-Up for female subjects only; LMP on Day -1 of Sessions. 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. 6/13/18 6/13/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 13, 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

Pregnancy Test and last menstrual Period

Adminitrative Data
Description

Adminitrative Data

Alias
UMLS CUI-1
C1320722
Type of Visit
Description

Complete Form for each of the Visits in this Item, if attended by female subject.

Data type

integer

Alias
UMLS CUI [1]
C0545082
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Date sample Taken

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0032976
Results
Description

Results

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Last Menstrual Period
Description

Last Menstrual Period

Alias
UMLS CUI-1
C0025329
Date of last menstrual Period
Description

Not neccessary at Early Withdrawal and Follow up.

Data type

date

Alias
UMLS CUI [1]
C0425932

Similar models

Pregnancy Test and last menstrual Period

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adminitrative Data
C1320722 (UMLS CUI-1)
Item
Type of Visit
integer
C0545082 (UMLS CUI [1])
Code List
Type of Visit
CL Item
Screening (1)
CL Item
Session 1 (Day -1) (2)
CL Item
Session 2 (Day -1) (3)
CL Item
Early Withdrawal (4)
CL Item
Follow-Up (5)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Date sample Taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Results
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Last Menstrual Period
C0025329 (UMLS CUI-1)
Date of Last menstrual period
Item
Date of last menstrual Period
date
C0425932 (UMLS CUI [1])

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