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Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

Cystic Fibrosis Clinical Trial

Official title:
A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient

Clinical Trial Summary

Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug. Creon is an approved drug for the treatment of EPI due to CF or CP. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States. Participants will receive oral capsules of CREON for 112 days and will be followed for 30 days. Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05069597
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 4
Start date October 14, 2021
Completion date August 28, 2023
View Details
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