The Effect of Oxytocin on Gastric Emptying

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by Skane University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Skane University Hospital

ClinicalTrials.gov Identifier:

NCT01152047

First received: June 23, 2010

Last updated: June 28, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 23, 2010
Last Updated Date	June 28, 2010
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 28, 2010)	Satiety [ Time Frame: 2 h ] [ Designated as safety issue: No ] The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient To see if oxytocin lowers satiety [ Time Frame: 2h ] [ Designated as safety issue: No ] To perform a drinking satiety test twice. Once with oxytocin and once with saline. Then examine whether oxytocin decreases satiety compared to saline
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01152047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Oxytocin on Gastric Emptying
Official Title ^ICMJE	The Effect of Oxytocin on Satiety in Patients With Dyspepsia
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	Dyspepsia Satiety
Intervention ^ICMJE	Drug: oxytocin 40mU/min as infusion of oxytocin
Study Arm (s)	Experimental: oxytocin, satiety Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test Intervention: Drug: oxytocin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	October 2010
Estimated Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Dyspepsia Exclusion Criteria: Age > 65 years Cardiac disease
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01152047
Other Study ID Numbers ^ICMJE	2009/502, 2009/502
Has Data Monitoring Committee	No
Responsible Party	Bodil Ohlsson, MD, PhD, Department of Clinical Sciences
Study Sponsor ^ICMJE	Skane University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Skane University Hospital
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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