A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

What Was Tested

This registered phase 3 trial tested Secretin.

It had two arms (groups): ChiRhoStim (active comparator) and Placebo (placebo comparator).

Human Secretin for Injection.

Saline for Injection.

The registry classes the interventions as drug.

Who Took Part

64 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer. Undergoing Endoscopic Procedure. Age ≥ 18 years. Willing and able to sign informed consent, meeting IRB guidelines. Willing and able to meet all study requirements and obligations.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: ongoing, active pancreatitis at the time of the procedure; known adverse reaction to secretin; recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Secretin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Secretin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2007-10 with completion listed for 2009-11.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Endoscopic Sample (time frame: First 5 minutes after treatment administration).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Secretin in 64 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Secretin compound page, all human trials.