The Effect of Oxytocin on Gastric Emptying | NCT01152047

Studies
The Effect of Oxytocin on Gastric Emptying

NCT01152047

Sponsor

Skane University Hospital

Status

Completed

Last Update Posted

Apr 7, 2015Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Dyspepsia
Lack of Satiety

Interventions

oxytocin

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009/502	Other Identifier	Regional Ethical Review Board

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jun 23, 2010

First Submission Date that Met QC Criteria

Jun 28, 2010

First Posted Date

Jun 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bodil Ohlsson, Department of Clinical Sciences, Division of Internal Medicine, Skane University HospitalPrincipal Investigator

Lead Sponsor

Skane University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients will come twice for a slow satiety drinking test. Once they will get saline infusion and once oxytocin 40 mU/min. At the same time they register satiety on a VAS scale.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oxytocin, satiety	Experimental	Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test	Drug: oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxytocin	Drug	40mU/min as infusion of oxytocin	oxytocin, satiety	syntocinon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satiety	The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient	2 h

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
To see if oxytocin lowers satiety	To perform a drinking satiety test twice. Once with oxytocin and once with saline. Then examine whether oxytocin decreases satiety compared to saline	2h

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dyspepsia

Exclusion Criteria:

Age > 65 years
Cardiac disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bodil Ohlsson, professor	Divsion of Internal Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skåne University Hospital		Malmö		205 02	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D004415	Dyspepsia

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided