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The Effect of Oxytocin on the Gastric Emptying

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ClinicalTrials.gov Identifier: NCT00776360
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Bodil Ohlsson, Skane University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Postprocedural Delayed Gastric Emptying Drug: oxytocin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Oxytocin on Gastric Emptying in Patients With Gastro Paresis
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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 Name: syntocinon

Drug: oxytocin
80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
Other Name: syntocinon

Placebo Comparator: oxytocin
sodium chloride is given to study gastric emptying rate
Drug: oxytocin
80mIE/min as continuous infusion for 70 minutes
Other Name: syntocinon

Drug: oxytocin
80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
Other Name: syntocinon




Primary Outcome Measures :
  1. To examine whether oxytocin improves gastric emptying in gastroparesis [ Time Frame: dec 2008-dec 22009 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gastroparesis in diabetics

Exclusion Criteria:

  • Treatment with other prokinetics, other severe organic or psychological diseases
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Responsible Party: Bodil Ohlsson, Department of Clinical Sciences, Division of Internal Medicine, Skane University Hospital
ClinicalTrials.gov Identifier: NCT00776360    
Other Study ID Numbers: 29/2008
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Bodil Ohlsson, Skane University Hospital:
oxytocin
gastroparesis
diabetics
The effect of oxytocin on gastric emptying
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs