The Effect of Oxytocin on the Gastric Emptying

Postprocedural Delayed Gastric Emptying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776360
• Other study ID #: 29/2008
• Status: Completed
• Phase: Phase 0
• First received: October 17, 2008
• Last updated: April 6, 2015
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2015
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Gastroparesis in diabetics

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis
• Postprocedural Delayed Gastric Emptying

Intervention

Drug:
• oxytocin
80mIE/min as continuous infusion for 70 minutes
• oxytocin
80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine whether oxytocin improves gastric emptying in gastroparesis		dec 2008-dec 22009	No