Back to resultsThe Effect of Oxytocin on the Gastric Emptying
Primary Purpose
Postprocedural Delayed Gastric Emptying
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
oxytocin
oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Postprocedural Delayed Gastric Emptying focused on measuring oxytocin, gastroparesis, diabetics, The effect of oxytocin on gastric emptying
Eligibility Criteria
Inclusion Criteria:
- Gastroparesis in diabetics
Exclusion Criteria:
- Treatment with other prokinetics, other severe organic or psychological diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oxytocin, gastric emptying
oxytocin
Arm Description
Oxytocin is given to study the gastric emptying rate
sodium chloride is given to study gastric emptying rate
Outcomes
Primary Outcome Measures
To examine whether oxytocin improves gastric emptying in gastroparesis
Secondary Outcome Measures
Full Information
NCT ID
NCT00776360
First Posted
October 17, 2008
Last Updated
April 6, 2015
Sponsor
Skane University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00776360
Brief Title
The Effect of Oxytocin on the Gastric Emptying
Official Title
The Effect of Oxytocin on Gastric Emptying in Patients With Gastro Paresis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprocedural Delayed Gastric Emptying
Keywords
oxytocin, gastroparesis, diabetics, The effect of oxytocin on gastric emptying
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxytocin, gastric emptying
Arm Type
Experimental
Arm Description
Oxytocin is given to study the gastric emptying rate
Arm Title
oxytocin
Arm Type
Placebo Comparator
Arm Description
sodium chloride is given to study gastric emptying rate
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
80mIE/min as continuous infusion for 70 minutes
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
Primary Outcome Measure Information:
Title
To examine whether oxytocin improves gastric emptying in gastroparesis
Time Frame
dec 2008-dec 22009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gastroparesis in diabetics
Exclusion Criteria:
Treatment with other prokinetics, other severe organic or psychological diseases
12. IPD Sharing Statement
Learn more about this trial
The Effect of Oxytocin on the Gastric Emptying
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