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Enzyme Replacement Therapy

CREON for Chronic Pancreatitis

Phase 4
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline), 8, 15, 29, and 85
Awards & highlights

Summary

This trial tests Creon, a medication that helps with digestion by providing necessary enzymes, in adults with cystic fibrosis or chronic pancreatitis. These patients have trouble digesting food because their pancreas doesn't produce enough enzymes. Creon works by releasing these enzymes in the stomach to aid in breaking down food.

Eligible Conditions
  • Chronic Pancreatitis
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline), 8, 15, 29, and 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline), 8, 15, 29, and 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

Side effects data

From 2023 Phase 4 trial • 30 Patients • NCT05069597
21%
DIARRHOEA
17%
ABDOMINAL PAIN
14%
ABDOMINAL DISTENSION
7%
VIRAL UPPER RESPIRATORY TRACT INFECTION
7%
FLATULENCE
3%
INTESTINAL OBSTRUCTION
3%
ALCOHOL POISONING
3%
FEMUR FRACTURE
3%
ALCOHOL ABUSE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment: Creon-AAPIS
Run-in: Creon-ABT

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Period: Creon-AAPISExperimental Treatment1 Intervention
Participants will receive Creon-AAPIS daily for 85 days.
Group II: Run-in Period: Creon-ABTExperimental Treatment1 Intervention
Participants will receive Creon-ABT daily for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CREON
2021
Completed Phase 4
~100

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,010 Previous Clinical Trials
518,716 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
435 Previous Clinical Trials
159,996 Total Patients Enrolled
~8 spots leftby Oct 2025
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