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NCT04949828 Clinical Trial

Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Chronic Pancreatitis Clinical Trial

— CisCP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04949828
Other study ID # P20-238
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 16, 2021
Est. completion date February 29, 2024

Study information
Verified date March 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CREON
Oral Capsules

Locations
Country Name City State
United States John Hopkins University /ID# 227061 Baltimore Maryland
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 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

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire Up to 1 month
Secondary Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue Up to 1 month
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