NCT01152047

Brief Summary

The investigators have seen that oxytocin lowers satiety in healthy subjects. Patients with dyspepsia suffers from decreased accommodation and increased satiety postprandially. The investigators now want to examine whether oxytocin may diminish symptoms in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

4.9 years

First QC Date

June 23, 2010

Last Update Submit

April 6, 2015

Conditions

DyspepsiaLack of Satiety

Keywords

oxytocinsatietydyspepsia

Outcome Measures

Primary Outcomes (1)

  • Satiety

    The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient

    2 h

Other Outcomes (1)

  • To see if oxytocin lowers satiety

    2h

Study Arms (1)

oxytocin, satiety

EXPERIMENTAL

Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test

Drug: oxytocin

Interventions

oxytocinDRUG

40mU/min as infusion of oxytocin

Also known as: syntocinon
oxytocin, satiety

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dyspepsia

You may not qualify if:

  • Age \> 65 years
  • Cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Bodil Ohlsson, professor

    Divsion of Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Clinical Sciences, Division of Internal Medicine

Study Record Dates

First Submitted

June 23, 2010

First Posted

June 29, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

SE(1)