← Back to Search

Enzyme Replacement Therapy

Pancrelipase for Cystic Fibrosis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 8 of each db treatment period

Awards & highlights

Study Summary

This study is evaluating whether a new formulation of a pancreatic enzyme may be as effective as the current formulation.

Eligible Conditions

Cystic Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 8 of each db treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 8 of each db treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 8 of each db treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 Coefficient of Fat Absorption (CFA)

Part 2 Coefficient of Fat Absorption (CFA)

Secondary outcome measures

Coefficient of Nitrogen Absorption (CNA)

Stool Fat

Stool Weight

Side effects data

From 2022 Phase 4 trial • 36 Patients • NCT03924947

NAUSEA

100%

80%

60%

40%

20%

Study treatment Arm

Part 2 DB Creon AAPIS

Part 1 DB Creon

Part 2 DB Creon

Part 2 OL Creon Post-Randomization

Part 1 OL Creon Pre-Randomization

Part 1 DB Creon MP

Part 1 OL Creon Post-Randomization

Part 2 OL Creon Pre-Randomization

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2 Double-Blind Creon AAPIS / CreonExperimental Treatment1 Intervention

After receiving open-label currently marketed Creon DR capsules during a pre-randomization period, participants receive double-blind Creon DR capsules manufactured at an alternate active pharmaceutical ingredient site (Creon AAPIS) in treatment period 1, followed by double-blind Creon DR capsules in treatment period 2. Participants also receive open-label currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.

Group II: Part 2 Double-Blind Creon / Creon AAPISExperimental Treatment1 Intervention

After receiving open-label currently marketed Creon DR capsules during a pre-randomization period, participants receive double-blind Creon DR capsules in treatment period 1, followed by double-blind Creon AAPIS in treatment period 2. Participants also receive open-label currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.

Group III: Part 1 Double-Blind Creon MP / CreonExperimental Treatment1 Intervention

After receiving open-label currently marketed Creon delayed release (Creon DR) capsules during a pre-randomization period, participants receive double-blind Creon DR capsules manufactured by modernized process pellets (Creon MP) in treatment period 1, followed by double-blind Creon DR capsules in treatment period 2. Participants also receive open-label currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.

Group IV: Part 1 Double-Blind Creon / Creon MPExperimental Treatment1 Intervention

After receiving open-label currently marketed Creon DR capsules during a pre-randomization period, participants receive double-blind Creon DR capsules in treatment period 1, followed by double-blind Creon MP in treatment period 2. Participants also receive open-label currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pancrelipase

2011

Completed Phase 4

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

501,069 Total Patients Enrolled

9 Trials studying Cystic Fibrosis

1,657 Patients Enrolled for Cystic Fibrosis

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

101,521 Total Patients Enrolled

2 Trials studying Cystic Fibrosis

78 Patients Enrolled for Cystic Fibrosis

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,903 Total Patients Enrolled

5 Trials studying Cystic Fibrosis

180 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Recent research and studies

clinicaltrials.govStudy

A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

2019. "A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03924947.

~7 spots leftby Apr 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.