Creon for Pancreatic Insufficiency

No longer recruiting at 27 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: AbbVie

Must be taking: Creon

Disqualifiers: Digestive tract malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well Creon, a pancreatic enzyme replacement therapy, alleviates symptoms of exocrine pancreatic insufficiency (EPI) in adults with cystic fibrosis (CF) or chronic pancreatitis (CP). EPI occurs when the pancreas fails to produce enough enzymes for digestion, a common issue in individuals with CF or CP. Participants will take Creon capsules daily for 113 days, and researchers will monitor symptom changes over time. Individuals diagnosed with CF or CP who have controlled EPI symptoms might be suitable for this study. As a Phase 4 trial, Creon is already FDA-approved and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that CREON is generally safe and well-tolerated. CREON helps replace enzymes for those whose pancreas doesn't produce enough for digestion, a condition known as exocrine pancreatic insufficiency (EPI).

In various studies, some individuals experienced mild side effects like an upset stomach. It's important to avoid exceeding the recommended dose to prevent more serious side effects. CREON has proven safe for both adults and children with EPI. While some might encounter minor issues, the treatment is considered safe for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

CREON is unique because it is specifically designed to address symptoms of exocrine pancreatic insufficiency (EPI) in conditions like cystic fibrosis and chronic pancreatitis. Unlike other treatments that simply replace digestive enzymes, CREON combines a carefully balanced mix of these enzymes to improve digestion more effectively. Researchers are excited about CREON because it has the potential to optimize nutrient absorption and improve patients' quality of life significantly. Additionally, its formulation is tailored to work throughout the digestive tract, ensuring enzymes are released when and where they are needed most.

What is the effectiveness track record for Creon in treating exocrine pancreatic insufficiency?

Research shows that Creon effectively treats exocrine pancreatic insufficiency (EPI), a condition where the pancreas doesn't produce enough enzymes for digestion. Studies have found that Creon improves digestion and nutrient absorption in people with EPI due to cystic fibrosis (CF) or chronic pancreatitis (CP). Specifically, Creon manages poor digestion and related symptoms in these patients. It is approved for use in both adults and children with EPI, highlighting its proven safety and effectiveness. Current evidence supports Creon as a reliable treatment option for managing EPI symptoms. In this trial, participants will receive either Creon-AAPIS or Creon-ABT, both studied for their effectiveness in treating EPI. ^{4 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been diagnosed with a condition called exocrine pancreatic insufficiency (EPI), but it is currently under control with treatment.

You have been previously diagnosed with cystic fibrosis or chronic pancreatitis.

Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

Exclusion Criteria

You have had cancer in your digestive tract within the last 5 years, or any other serious medical condition that may impact the assessment of your symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants receive Creon-ABT daily to establish baseline and ensure tolerance

4 weeks

Regular visits (in-person or telemedicine)

Treatment Period

Participants receive Creon-AAPIS daily to assess treatment effects

12 weeks

Regular visits (in-person or telemedicine)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Regular visits (in-person or telemedicine)

What Are the Treatments Tested in This Trial?

Interventions

• CREON

How Is the Trial Designed?

Group I: Treatment Period: Creon-AAPIS Experimental Treatment 1 Intervention

Participants will receive Creon-AAPIS daily for 85 days.

Group II: Run-in Period: Creon-ABT Experimental Treatment 1 Intervention

Participants will receive Creon-ABT daily for 28 days.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1569199309001222

Efficacy and safety of Creon® 24000 in subjects with ... These data demonstrate that Creon 24,000 capsules are an effective treatment for maldigestion with resultant malabsorption associated with EPI due to CF.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10454644/

Survey of Pancreatic Enzyme Replacement Therapy Dosing ... This study delves into the real-world experiences of individuals with EPI regarding their PERT usage.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03859869

A Study of Creon (Pancrelipase) in Resected and Non- ... Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/020725s031lbl.pdf

Creon - accessdata.fda.gov The safety and effectiveness of CREON for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of CREON for ...

5. creonhcp.com creonhcp.com/

CREON® (pancrelipase) Delayed-Release Capsules - Official ... CREON (pancrelipase) delayed-release capsules are indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

6. creonhcp.com creonhcp.com/safety-data

CREON® (pancrelipase) Safety Data - HCP Site CREON has a well-characterized safety profile. Safety data collected from clinical trials of CREON in various patient populations.

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9ABOTP_CREON_CAP.pdf

Product Name: Creon Issued: Jun-18-2012 Clinical data suggests the following: gastrointestinal upset. Medical Conditions. Aggravated by Exposure: None known from occupational exposure.

8. creoninfo.com creoninfo.com/

CREON® Official Website - For Exocrine Pancreatic Insufficiency CREON (pancrelipase) is a pancreatic enzyme replacement therapy for EPI patients. Learn more about EPI, as well as CREON dosing, side effects, and risks.

9. patientsupport.creoninfo.com patientsupport.creoninfo.com/hcp/resources

CREON Complete Patient Resources Important Safety Information. Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Do not exceed the recommended dosage ...