Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

NCT04231279 | Terminated Phase 3 FDA Drug

• 2 other identifiers: RAP and EPI1804804
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 3-year prospective study too identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy. An endoscopic pancreatic function test (ePFT) with secretin will be performed in children undergoing routine investigative EGD. The goal of this study is to identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy, who otherwise would be labelled as recurrent abdominal pain (RAP).

Conditions

Abdominal Pain; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain

  Secretin stimulated exocrine pancreatic enzyme activity will be measured in patients with abdominal pain who are undergoing upper endoscopy to identify those with insufficiency (EPI).

  2.5 years

Secondary Outcomes (1)

• Secondary biomarkers for exocrine pancreatic insufficiency in blood and pancreatic fluid will be measured to explore mechanisms involved leading to abdominal pain and become potential tests in future.

  2.5 years

Study Arms (2)

ChiRhoStim Group 1

ACTIVE COMPARATOR

Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.

Drug: synthetic human secretin

ChiRhoStim Group 2

EXPERIMENTAL

Patients undergoing diagnostic EGD that consent to undergo ePFT.

Drug: synthetic human secretin

Interventions

synthetic human secretin DRUG

Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.

Also known as: ChiRhoStim

ChiRhoStim Group 1; ChiRhoStim Group 2

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For Group 1- Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency
• For Group 2- Patients undergoing diagnostic EGD who consent to undergo ePFT

You may not qualify if:

• If it is an emergency EGD procedure
• If the caregiver refuses to sign the consent form
• Patient has undergone ePFT testing previously with a documented allergy to human secretin
• Patients that require atropine at the time of sedation

Sponsors & Collaborators

• Orlando Health, Inc.: lead
• ChiRhoClin, Inc.: collaborator

Study Sites (1)

Orlando Health - Arnold Palmer Children's Hospital

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Abdominal Pain; Irritable Bowel Syndrome

Interventions

Secretin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal 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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology Laboratory, Arnold Palmer Hospital for Children

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: January 28, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)