Secretin for Acute Pancreatitis

NCT03686618 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 2017-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pancreatitis is a frequently devastating pancreatic inflammatory process that results in extensive morbidity, mortality, and hospitalization costs. The incidence of acute pancreatitis has been increasing over the last decade with an overall mortality rate of 5%, although it may be as high as 30% in the most severe cases. 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. However, despite the significant impact to both patients and the healthcare system, there is no proven pharmacologic therapy that improves important clinical outcomes in acute pancreatitis. The release of bicarbonate rich fluid into the pancreatic duct from the ductal cells is an important mechanism to protect against pancreatitis by two distinct mechanisms:

1. 1."Flushing" activated enzymes out of the pancreas and into the duodenum thereby preventing accumulation of activated enzymes within the pancreatic acinus
2. 2.Directly alkalinizing the acinar cells, which limits intra-acinar cell damage by improving trafficking of inappropriately activated intra-acinar enzymes along the apical membrane.

Conditions

Pancreatitis, Acute

Outcome Measures

Primary Outcomes (1)

• Change in CRP level

  Change in serum C-reactive protein (CRP) level by 50% within 96 hours and/or at discharge compared with CRP level at admission to determine optimal frequency of dosing

  96 hours and through study completion an average of day 7

Secondary Outcomes (1)

• Pro- and anti-inflammatory markers

  Day 1, Day 2, Day 3, 96 hours and through study completion an average of day 7

Other Outcomes (6)

• Change in Hemoconcentration measurement

  96 hours and through study completion an average of day 7

• Change in Hemoconcentration measurements

  96 hours and through study completion an average of day 7

• Acute Pancreatitis Activity Score

  96 hours and through study completion an average of day 7

Study Arms (4)

Cohort X

NO INTERVENTION

no secretin administered. All observations

Cohort 1

ACTIVE COMPARATOR

32 mcg (\<50kg) or 40 mcg (≥50kg) secretin two times a day (40 mcg; q 12 hrs)

Drug: Secretin

Cohort 2

ACTIVE COMPARATOR

32 mcg (\<50kg) or 40 mcg (≥50kg) secretin four times a day (40 mcg; q 6 hrs)

Drug: Secretin

Cohort 3

ACTIVE COMPARATOR

32 mcg (\<50kg) or 40 mcg (≥50kg) secretin six times a day (40 mcg; q 4 hrs)

Drug: Secretin

Interventions

Secretin DRUG

Drug to stimulate pancreatic secretion

Also known as: ChiRhoStim®

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male or female ≥18 years of age
• Patient voluntarily signed written, informed consent agreement.
• If patient is female and not more than 1 year post-menopausal, or surgically sterile, must use medically accepted form of contraception or abstain from sexual activities during study
• Patient has acute pancreatitis as defined by the Atlanta Classification of 2012
• No evidence of obstructive pancreatitis on available cross-sectional imaging

You may not qualify if:

• 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

Sponsors & Collaborators

• ChiRhoClin, Inc.: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Pancreatitis

Interventions

Secretin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Timothy B Gardner, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy B Gardner, MD

CONTACT

603-650-6472; timothy.b.gardner@hitchcock.org

Damara Crate, RN

CONTACT

603-653-9017; damara.j.crate@hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is not blinded and does not require any randomization codes. Ten patients each will receive one of three treatments for Days 1, 2, and 3: 1. No secretin - standard of care and observation (Cohort X) 2. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 12 hours (Cohort 1) 3. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 6 hours (Cohort 2) 4. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 4 hours (Cohort 3)

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 27, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)