The Effect of Oxytocin on the Gastric Emptying

April 6, 2015 updated by: Bodil Ohlsson, Skane University Hospital

The Effect of Oxytocin on Gastric Emptying in Patients With Gastro Paresis

The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.The gastric emptying is estimade by sitntigraphy during 70 minutes, and performed twicw. Once with saline and once with oxytocin.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gastroparesis in diabetics

Exclusion Criteria:

  • Treatment with other prokinetics, other severe organic or psychological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oxytocin, gastric emptying
Oxytocin is given to study the gastric emptying rate
Drug: oxytocin
80mIE/min as continuous infusion for 70 minutes
Other Names:
  • syntocinon
Drug: oxytocin
80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
Other Names:
  • syntocinon
Placebo Comparator: oxytocin
sodium chloride is given to study gastric emptying rate
Drug: oxytocin
80mIE/min as continuous infusion for 70 minutes
Other Names:
  • syntocinon
Drug: oxytocin
80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
Other Names:
  • syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To examine whether oxytocin improves gastric emptying in gastroparesis
Time Frame: dec 2008-dec 22009
dec 2008-dec 22009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skane University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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