ID

30543

Beskrivning

This ODM file contains Holter and Telemetry Results. Holter part to be filled at Screening, Session 1 and 2 (Day -1 and Day 1), Telemetry part to be filled at Sessions 1 and 2 (Day 1 only). 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.

Länk

https://clinicaltrials.gov/ct2/show/NCT01039454

Nyckelord

Versioner (1)
  1. 13-06-18 13-06-18 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 juni 2018

DOI

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Licens

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

Engelsk

Holter (Screening, Session 1+2), Telemetry (Session 1 + 2)

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Type of Visit
Beskrivning

Visit

Datatyp

text

Alias
UMLS CUI [1]
C0545082
Holter
Beskrivning

Holter

Alias
UMLS CUI-1
C0013801
Planned relative Time on Day 1 of Sessions.
Beskrivning

Not to be filled at Screening or Day -1 of Sessions.

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0013801
Start Date of Holter
Beskrivning

Record the dates and times recorded by the Holter monitoring equipment.

Datatyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Beskrivning

Record the dates and times recorded by the Holter monitoring equipment.

Datatyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop Date of Holter
Beskrivning

Record the dates and times recorded by the Holter monitoring equipment.

Datatyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Stop Time of Holter
Beskrivning

Record the dates and times recorded by the Holter monitoring equipment.

Datatyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Holter monitoring method
Beskrivning

Holter monitoring method

Datatyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
Interpretation of Holter
Beskrivning

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional Holter abnormalities page if clinically significant abnormalities are present.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
Telemetry
Beskrivning

Telemetry

Alias
UMLS CUI-1
C0039451
Planned relative Time on Day 1 of Sessions
Beskrivning

Telemetry only mandatory on day 1 of Sessions. Not to be done at screening or Day -1 of Sessions.

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0039451
Start date of Telemetry
Beskrivning

Start date of Telemetry

Datatyp

date

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0808070
Start time of Telemetry
Beskrivning

Start time of Telemetry

Datatyp

time

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1301880
End date of Telemetry
Beskrivning

End date of Telemetry

Datatyp

date

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0806020
End time of Telemetry
Beskrivning

End time of Telemetry

Datatyp

time

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1522314
Result of Telemetry
Beskrivning

Result of Telemetry

Datatyp

integer

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1274040
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Similar models

Holter (Screening, Session 1+2), Telemetry (Session 1 + 2)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Visit
Code List
Type of Visit
CL Item
Screening (Screening)
(Comment:en)
CL Item
Session 1 (Day 1) (Session 1 (Day 1))
(Comment:en)
CL Item
Session 2 (Day 1) (Session 2 (Day 1))
(Comment:en)
CL Item
Unscheduled (Unscheduled)
(Comment:en)
CL Item
Session 1 (Day -1) (Session 1 (Day -1))
(Comment:en)
CL Item
Session 2 (Day -1) (Session 2 (Day -1))
(Comment:en)
Item Group
Holter
C0013801 (UMLS CUI-1)
Item
Planned relative Time on Day 1 of Sessions.
text
C0439564 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
Planned relative Time
Code List
Planned relative Time on Day 1 of Sessions.
CL Item
Pre-Scan (Pre-Scan)
CL Item
Post-Scan (Post-Scan)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date of Holter
Item
Stop Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time of Holter
Item
Stop Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Holter monitoring method
text
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Holter monitoring method
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 lead 180Hz (2)
CL Item
3 Lead 180 Hz (3)
CL Item
Telemetry (4)
CL Item
5 Lead 512Hz (5)
CL Item
4 Lead 0.05-40 Hz (6)
CL Item
6 Lead 0.05-40 Hz (7)
CL Item
7 Lead 0.05-100 Hz-3dB (8)
CL Item
7 Lead 3 channel 133 Hz (9)
CL Item
2 Lead 200 Hz (10)
CL Item
Other (OT)
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of ECG
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
abnormal - clinically significant (3)
CL Item
no result (4)
CL Item
unable to evaluate (8)
Item Group
Telemetry
C0039451 (UMLS CUI-1)
Item
Planned relative Time on Day 1 of Sessions
text
C0439564 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
Planned relative Time
Code List
Planned relative Time on Day 1 of Sessions
CL Item
Pre-Scan (Pre-Scan)
CL Item
Post-Scan (Post-Scan)
Start date of Telemetry
Item
Start date of Telemetry
date
C0039451 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of Telemetry
Item
Start time of Telemetry
time
C0039451 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End date of Telemetry
Item
End date of Telemetry
date
C0039451 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End time of Telemetry
Item
End time of Telemetry
time
C0039451 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of Telemetry
integer
C0039451 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of ECG
Code List
Result of Telemetry
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
abnormal - clinically significant (3)
CL Item
no result (4)
CL Item
unable to evaluate (8)
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