Phase 4
N=30
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
Cystic Fibrosis · Chronic Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT05069597 ↗Enrolled (actual)
30
Serious AEs
3.4%
Results posted
Jul 2024
Primary outcome: Primary: Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 — 0.0012; 0.0480; 0.1506; 0.0791 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CREON (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 |
0.0012; 0.0480; 0.1506; 0.0791 | — |
| PRIMARY Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 |
0.0582; 0.0530; 0.1905; 0.0893 | — |
| PRIMARY Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 |
-0.0555; 0.0432; 0.1111; 0.0695 | — |
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. 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05069597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.