ID

30875

Description

This ODM file contains documentation of concomitant medications. To be checked for (and added if neccessary) at Screening, Sessions 1 and 2 (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 (2)
  1. 6/29/18 6/29/18 - Sarah Riepenhausen
  2. 6/29/18 6/29/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 29, 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

Concomitant Medications

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Description

If Yes, record each medication in a separate set of the following questions of this itemgroup using Trade Names where possible.

Data type

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Description

Trade name preferred, e.g. Aspirin

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Unit Dose
Description

Unit Dose

Data type

float

Alias
UMLS CUI [1]
C2826767
Units
Description

Examples: Abbreviation = Label TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency
Description

Examples: Abbreviation = Label OD/QD = 1 x Daily BID = 2 x Daily TID = 3 x Daily QID = 4 x Daily PRN = As required

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Examples: Abbreviation = Label IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal

Data type

text

Alias
UMLS CUI [1]
C2826730
Reason for Medication
Description

Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: Current Medical Conditions Non-Serious Adverse Events Serious Adverse Events Form

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date
Description

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit. Record Unknown months as UNK

Data type

date

Alias
UMLS CUI [1]
C2826734
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken Prior to Study
Description

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Data type

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Data type

date

Alias
UMLS CUI [1]
C2826744
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
Ongoing Medication?
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Planned relative Time
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
float
C2826767 (UMLS CUI [1])
Units
Item
Units
text
C2826646 (UMLS CUI [1])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date Concomitant Medication
Item
Start Date
date
C2826734 (UMLS CUI [1])
Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Taken Prior to Study
text
C2826667 (UMLS CUI [1])
Taken Prior to Study
Code List
Taken Prior to Study
CL Item
Yes (Y)
CL Item
No (N)
Stop Date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Planned relative Time
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
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