Skip to main content
OpenTrials
Completed

NCT Number: NCT05069597

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

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. 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 113 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Chronic Disease Chronic Pancreatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Velocity Clinical Research /ID# 231076, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
  • Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
  • Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

Exclusion criteria

  • Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

Treatment and study plan

CREON

Drug

Capsule; Oral

Other names: Pancrelipase

Primary outcomes

  1. Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

    Time frame: Day 1 (baseline), 8, 15, 29, and 85

    The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.

  2. Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

    Time frame: Day 1 (Baseline), 8, 15, 29, and 85

    The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.

  3. Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

    Time frame: Day 1 (Baseline), 8, 15, 29, and 85

    The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2021
Registry last updated
Jul 23, 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.

Related clinical trials

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