Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Exocrine Pancreatic Insufficiency Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CREON

Drug

Oral Capsules

Other names: pancrelipase, ABT-SLV245

Primary outcomes

Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire

Time frame: Up to 1 month

Secondary outcomes

Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue

Time frame: Up to 1 month

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)

Acronym: CisCP

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jul 2, 2021
Registry last updated: Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed