NCT01134848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

Enrollment Period

1.1 years

First QC Date

May 28, 2010

Last Update Submit

June 1, 2010

Conditions

Sphincter of Oddi Dysfunction

Keywords

Bile ductsSphincter of OddiPancreatic ducts

Outcome Measures

Primary Outcomes (3)

  • Serum amylase (U/L)

    0, 60, 120, 180 and 240 minutes

  • Serum lipase (U/L)

    0, 60, 120, 180 and 240 minutes

  • Liver function tests

    0, 60, 120, 180 and 240 minutes

Secondary Outcomes (4)

  • Pancreatic duct diameter (mm)

    0, 5, 30, 60, 90, 120, 150 and 180 minutes

  • Pancreatic duct length (mm)

    0, 5, 30, 60, 90, 120, 150 and 180 minutes

  • Common bile duct diameter (mm)

    0, 5, 30, 60, 90, 120, 150 and 180 minutes

  • Gallbladder volume (mm3)

    0, 5, 30, 60, 90, 120, 150 and 180 minutes

Study Arms (2)

Morphine-neostigmine

ACTIVE COMPARATOR
Drug: MorphineDrug: NeostigmineDrug: 0.9% saline

Secretin

ACTIVE COMPARATOR
Drug: SecretinDrug: 0.9% saline

Interventions

MorphineDRUG

10mg IM

Morphine-neostigmine
NeostigmineDRUG

1mg IM

Morphine-neostigmine
0.9% salineDRUG

0.1 ml/kg

Morphine-neostigmine
SecretinDRUG

1 unit/kg IV

Secretin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy age matched and sex matched volunteers
  • No history of chronic abdominal pain
  • No previous abdominal surgery
  • No history suggestive of gastrointestinal motility disorders
  • No history of regular medication or substance abuse

You may not qualify if:

  • Acute illness within preceding 6 weeks
  • Participation in another study within 3 months
  • Allergy to morphine or neostigmine
  • Pregnancy
  • Refusal to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Sphincter of Oddi Dysfunction

Interventions

MorphineNeostigmineSaline SolutionSecretin

Condition Hierarchy (Ancestors)

Biliary DyskinesiaCommon Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Dileep Lobo, MBBS DM FRCS

    University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Abeed Chowdhury, MB ChB BSc MRCS

    University of Nottingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2010

First Posted

June 2, 2010

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

GB(1)