The Effect of Oxytocin on Gastric Emptying

Tracking Information
First Submitted Date ICMJE	June 23, 2010
First Posted Date ICMJE	June 29, 2010
Last Update Posted Date	April 7, 2015
Study Start Date ICMJE	May 2010
Actual Primary Completion Date	April 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 6, 2015)	Satiety [ Time Frame: 2 h ]; The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient
Original Primary Outcome Measures ICMJE; (submitted: June 28, 2010)	Satiety [ Time Frame: 2 h ]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 ]To perform a drinking satiety test twice. Once with oxytocin and once with saline. Then examine whether oxytocin decreases satiety compared to saline
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; (submitted: April 6, 2015)	To see if oxytocin lowers satiety [ Time Frame: 2h ]; To perform a drinking satiety test twice. Once with oxytocin and once with saline. Then examine whether oxytocin decreases satiety compared to saline
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 Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
Condition ICMJE	Dyspepsia; Lack of Satiety
Intervention ICMJE	Drug: oxytocin; 40mU/min as infusion of oxytocin; Other Name: syntocinon
Study Arms	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	Completed
Actual Enrollment ICMJE; (submitted: April 6, 2015)	14
Original Estimated Enrollment ICMJE; (submitted: June 28, 2010)	30
Actual Study Completion Date	April 2015
Actual Primary Completion Date	April 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Dyspepsia Exclusion Criteria: Age > 65 years; Cardiac disease
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Sweden
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01152047
Other Study ID Numbers ICMJE	2009/502; 2009/502 ( Other Identifier: Regional Ethical Review Board )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bodil Ohlsson, Skane University Hospital
Study Sponsor ICMJE	Skane University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Bodil Ohlsson, professor Divsion of Internal Medicine
PRS Account	Skane University Hospital
Verification Date	April 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP