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Enzyme Replacement Therapy

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

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
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
2022
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,035 Previous Clinical Trials
523,014 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,663 Total Patients Enrolled
~7 spots leftby Dec 2025
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