Secretin for Acute Pancreatitis

What Was Tested

In this phase 2 trial, researchers set out to test Secretin.

Acute pancreatitis is a frequently devastating pancreatic inflammatory process that results in extensive morbidity, mortality, and hospitalization costs.

It was the most common inpatient gastrointestinal diagnosis in 2009, totaling over 270,000 hospitalizations with estimated "inpatient costs" of over 2.5 billion dollars in the United States.

It had four arms (groups): Cohort X (no intervention), Cohort 1 (active comparator), Cohort 2 (active comparator) and Cohort 3 (active comparator).

No secretin administered. All observations.

The registry classes the interventions as drug.

More on the Plan

All enrolled patients will receive standard of care therapy in regard to fluid resuscitation, pain control, CT scan or ultrasound imaging and nutritional support.

In addition to standard of care, patients will be divided into 4 cohorts of 10 patients.

Cohort X will not receive drug.

Patients will continue to be followed until discharge.

Who Took Part

The registry lists 40 planned participants were the target.

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: Patient is male or female ≥18 years of age. Patient voluntarily signed written, informed consent agreement. Patient has acute pancreatitis as defined by the Atlanta Classification of 2012. No evidence of obstructive pancreatitis on available cross-sectional imaging.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: pancreatitis with duct obstruction or severe acute pancreatitis defined by atlanta classification; pregnant woman, nursing mothers, or women of childbearing potential not on birth control; known adverse reaction to human secretin.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Secretin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Secretin study: the participants and staff both knew the treatment.

It started in 2018-10-01 with completion listed for 2019-10-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in CRP level (time frame: 96 hours and through study completion an average of day 7).

It also tracked 1 secondary outcome, for example Pro- and anti-inflammatory markers.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Secretin in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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