Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04949828

Acronym

CisCP

Enrollment

Registered

2021-07-02

Start date

2021-09-16

Completion date

2024-02-29

Last updated

2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

Keywords

Chronic pancreatitis, Exocrine Pancreatic Insufficiency, CREON, pancrelipase, ABT-SLV245

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.

Interventions

DRUGCREON

Oral Capsules

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026