ID

30995

Description

This ODM file contains Dates of Laboratory Sample Taking (general, Haematology, Clinical Chemistry and Urinalysis). To be filled at Screening, Session 1 and 2 (Day -1 and Day 1, different extent and timepoints), 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

  1. 6/8/18 6/8/18 - Sarah Riepenhausen
  2. 7/9/18 7/9/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

July 9, 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

Laboratory Data (All Part A Visits)

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Description

Form needs to be filled out on each attended visit mentioned below.

Data type

text

Alias
UMLS CUI [1]
C0545082
Electronically transferred Laboratory Data
Description

Electronically transferred Laboratory Data

Alias
UMLS CUI-1
C1705214
Relative Time for Sessions 1 and 2
Description

Question only relevant for Session visits. Pre-dose and 2 hrs post-dose general Laboratory data, other relative times haematology, clinical chemistry and urinalysis. 72 hrs post-dose only necessary if 48 hrs post-dose assessments are abnormal.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0022885
Type of Laboratory Data
Description

General/Unspecified: only to be chosen for Session 1/2 Day 1, pre-dose and 2 hrs post-dose. All other Session timepoints as well as all other visits need Clinical Chemistry, Haematology and Urinalysis.

Data type

text

Alias
UMLS CUI [1]
C0022885
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Actual Time sample taken
Description

Time sample taken

Data type

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345

Similar models

Laboratory Data (All Part A Visits)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Code List
Subject Identifier
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Code List
Visit Type
CL Item
Screening (Screening)
CL Item
Session 1 (Session 1)
CL Item
Session 2 (Session 2)
CL Item
Follow-Up (Follow-Up)
CL Item
Early Withdrawal (Early Withdrawal)
Item Group
Electronically transferred Laboratory Data
C1705214 (UMLS CUI-1)
Item
Relative Time for Sessions 1 and 2
text
C0439564 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Code List
Relative Time for Sessions 1 and 2
CL Item
Day -1 (Day -1)
CL Item
Day 1, Pre-dose (Day 1, Pre-dose)
CL Item
Day 1, 2 hrs post-dose (Day 1, 2 hrs post-dose)
CL Item
Day 1, 24 hrs post-dose (Day 1, 24 hrs post-dose)
CL Item
Day 1, 48 hrs post-dose (Day 1, 48 hrs post-dose)
CL Item
Day 1, 72 hrs post-dose (Day 1, 72 hrs post-dose)
Item
Type of Laboratory Data
text
C0022885 (UMLS CUI [1])
Code List
Type of Laboratory Data
CL Item
General/Unspecified (General/Unspecified)
CL Item
Haematology (Haematology)
CL Item
Clinical Chemistry (Clinical Chemistry)
CL Item
Urinalysis (Urinalysis)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Time sample taken
Item
Actual Time sample taken
text
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])

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