drugset / Trial / NCT01134848

A Study of Serial Magnetic Resonance Cholangiopancreatography (MRCP) Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers

NCT01134848

Phase 4 Completed 10 enrolled University of Nottingham
RandomizedCrossoverTriple-blindDiagnostic

Summary

The sphincter of Oddi is a circular band of muscle which controls the flow of pancreatic juices and bile into the small intestine. Abnormal function of the Sphincter of Oddi, known as Sphincter of Oddi dysfunction (SOD), can lead to recurrent episodes of abdominal pain. Making a diagnosis of SOD is difficult and is currently achieved using an invasive pressure test. This pressure test is associated with some adverse effects including inflammation of the pancreas gland. We are investigating an alternative test in which medication is given to provoke spasm of the sphincter. Following provocation, blood can be sampled to detect changes in blood composition and changes in sphincter anatomy can be evaluated using specialized imaging techniques. Our aim is to study and compare the effects of two provocation medications (morphine-prostigmine and secretin) on biliary and pancreatic ductal anatomy, using dynamic serial MRCP in healthy volunteers. Our hypothesis is that morphine-neostigmine provocation results in greater changes in biliary and pancreatic ductal anatomy when assessed using dynamic serial MRCP.

Timeline

Start
2009-01
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Morphine Other / unclassified 10 mg Intramuscular
Comparator Neostigmine Other / unclassified 1 mg Intramuscular
Comparator Secretin Other / unclassified 1 iu/kg Intravenous

Indications