The Effect of Oxytocin on Gastric Emptying
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ClinicalTrials.gov Identifier: NCT01152047 |
Recruitment Status
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Completed
First Posted
: June 29, 2010
Last Update Posted
: April 7, 2015
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Sponsor:
Skane University Hospital
Information provided by (Responsible Party):
Bodil Ohlsson, Skane University Hospital
Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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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 |
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
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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 |
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Condition ICMJE |
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Intervention ICMJE | Drug: oxytocin
40mU/min as infusion of oxytocin
Other Name: syntocinon |
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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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
14 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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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 |
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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 |