ID

30543

Descrizione

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.

collegamento

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

Keywords

versioni (1)
  1. 13/06/18 13/06/18 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

13 giugno 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

  • i più nuovi
  • i più vecchi
  • Popolare
  • i più nuovi
    • i più nuovi
    • i più vecchi
    • Popolare

Non ci sono commenti

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

Inglese

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

1 moduli  
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Type of Visit
Descrizione

Visit

Tipo di dati

text

Alias
UMLS CUI [1]
C0545082
Holter
Descrizione

Holter

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

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

Tipo di dati

text

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

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

Tipo di dati

date

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

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

Tipo di dati

time

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

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

Tipo di dati

date

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

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

Tipo di dati

time

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

Holter monitoring method

Tipo di dati

text

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

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.

Tipo di dati

integer

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

Telemetry

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

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

Tipo di dati

text

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

Start date of Telemetry

Tipo di dati

date

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

Start time of Telemetry

Tipo di dati

time

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

End date of Telemetry

Tipo di dati

date

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

End time of Telemetry

Tipo di dati

time

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

Result of Telemetry

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1274040
Ritorna all'inizio della pagina

Similar models

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

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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)
Ritorna all'inizio della pagina 

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial