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

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

30 Participants Needed

Trial Summary

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 purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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)

Treatment Details

Interventions

• CREON

Participant Groups

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