Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Completed

• Conditions: Chronic Pancreatitis
• Interventions: Drug: CREON

• Registration Number: NCT04949828
• Lead Sponsor: AbbVie

Brief Summary

Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-02
• Study Start: 2021-09-16
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Medical history of chronic pancreatitis (CP).
• Diagnosis of Exocrine Pancreatic Insufficiency (EPI).

Exclusion Criteria

--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants on CREON	CREON	-

Primary Outcome Measures

Name	Time	Method
Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire	Up to 1 month

Secondary Outcome Measures

Name	Time	Method
Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue	Up to 1 month

Trial Locations

Locations (6)

John Hopkins University /ID# 227061; 🇺🇸 Baltimore, Maryland, United States

Baylor College of Medicine - Baylor Medical Center /ID# 227067; 🇺🇸 Houston, Texas, United States

NYU Langone Health /ID# 230818; 🇺🇸 New York, New York, United States

Stanford University School of Med /ID# 229530; 🇺🇸 Stanford, California, United States

The Ohio State University Wexner Medical Center /ID# 227844; 🇺🇸 Columbus, Ohio, United States

University of Florida - Archer /ID# 227057; 🇺🇸 Gainesville, Florida, United States