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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05069597

Collaborator

(none)

Enrollment

Locations

Arms

20.5

Anticipated Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug.

Creon is an approved drug for the treatment of EPI due to CF or CP. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States.

Participants will receive oral capsules of CREON for 112 days and will be followed for 30 days.

Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Chronic Pancreatitis	Drug: CREON	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient

Actual Study Start Date :

Oct 14, 2021

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Run-in Period: Creon Participants will receive Creon daily for 112 days.	Drug: CREON Capsule; Oral Other Names: Pancrelipase
Experimental: Treatment Period: Creon Participants will receive Creon daily for 112 days.	Drug: CREON Capsule; Oral Other Names: Pancrelipase

Arm

Intervention/Treatment

Experimental: Run-in Period: Creon

Participants will receive Creon daily for 112 days.

Drug: CREON

Capsule; Oral

Other Names:

Pancrelipase

Experimental: Treatment Period: Creon

Participants will receive Creon daily for 112 days.

Drug: CREON

Capsule; Oral

Other Names:

Pancrelipase

Outcome Measures

Primary Outcome Measures

Symptoms of Exocrine Pancreatic Insufficiency (EPI) [Day 1 through Day 85]
Mean symptom scores will be summarized.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

Exclusion Criteria:

Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedPharmics, LLC - Mobile /ID# 231076	Mobile	Alabama	United States	36608-1771
2	Valley Children's Hospital /ID# 231452	Madera	California	United States	93636
3	University of Florida - Archer /ID# 233411	Gainesville	Florida	United States	32610
4	Atlantic Medical Research Group /ID# 239568	Margate	Florida	United States	33063-5737
5	University of Miami, Miller School of Medicine /ID# 239415	Miami	Florida	United States	33136
6	GI Pros /ID# 239486	Naples	Florida	United States	34102-5449
7	Central FL Pulmonary Orlando /ID# 245863	Orlando	Florida	United States	32803
8	Asr, Llc /Id# 239566	Nampa	Idaho	United States	83687
9	UMass Chan Medical School /ID# 230476	Worcester	Massachusetts	United States	01655
10	The Curators of the University of Missouri /ID# 233331	Columbia	Missouri	United States	65211
11	Dartmouth-Hitchcock Medical Center /ID# 231633	Lebanon	New Hampshire	United States	03756
12	NYU Langone Health /ID# 233417	New York	New York	United States	10016-2708
13	Wake Forest Baptist Health /ID# 229537	Winston-Salem	North Carolina	United States	27157-0001
14	University of Cincinnati /ID# 229511	Cincinnati	Ohio	United States	45267-0585
15	UH Cleveland Medical Center /ID# 246065	Cleveland	Ohio	United States	44106
16	Cleveland Clinic Main Campus /ID# 245864	Cleveland	Ohio	United States	44195
17	Options Health Research, LLC /ID# 239535	Tulsa	Oklahoma	United States	74104
18	Baylor College of Medicine Medical Center /ID# 233441	Houston	Texas	United States	77030-4202
19	Univ Texas HSC San Antonio /ID# 239060	San Antonio	Texas	United States	78229-3901
20	Children's Hospital of Richmond at VCU /ID# 245988	Richmond	Virginia	United States	23298
21	West Virginia University Hospitals /ID# 239593	Morgantown	West Virginia	United States	26506