ID

30851

Beschreibung

This ODM file contains Randomisation Number, Investigational Product Date and Time and Treatment Confirmation. To be filled at Sessions 1 and 2 (Day 1; Randomisation only at Session 1). 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

Stichworte

  1. 27.06.18 27.06.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. Juni 2018

DOI

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Lizenz

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

Randomisation, Investigational Product and Treatment Confirmation (Sessions 1 and 2)

Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Type of Visit
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Randomisation Number
Beschreibung

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number
Beschreibung

Only mandatory at Session 1, Day 1.

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschreibung

Date of randomisation

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of actual dose
Beschreibung

Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Actual Dose
Beschreibung

Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Treatment Confirmation
Beschreibung

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Treatment confirmation

Datentyp

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If No, record reason(s)
Beschreibung

Reason for no treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0746919

Ähnliche Modelle

Randomisation, Investigational Product and Treatment Confirmation (Sessions 1 and 2)

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Code List
Type of Visit
CL Item
Session 1 (Day 1) (Session 1 (Day 1))
(Comment:en)
CL Item
Session 2 (Day 1) (Session 2 (Day 1))
(Comment:en)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Record randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of Dose
Item
Date of actual dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Actual Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No (N)
Reason for no treatment
Item
If No, record reason(s)
text
C0566251 (UMLS CUI [1,1])
C0746919 (UMLS CUI [1,2])

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