Clinical trial NCT05069597: Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Chronic Pancreatitis
Keywords: Cystic Fibrosis
Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Creon
Pancrelipase
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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. 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 113 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
timeFrame: Day 1 (baseline), 8, 15, 29, and 85
measure: Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
timeFrame: Day 1 (Baseline), 8, 15, 29, and 85
measure: Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
timeFrame: Day 1 (Baseline), 8, 15, 29, and 85
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Velocity Clinical Research /ID# 231076
state: Alabama
city: Madera
country: United States
facility: Valley Children's Hospital /ID# 231452
state: California
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 233411
state: Florida
city: Margate
country: United States
facility: Atlantic Medical Research /ID# 239568
state: Florida
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine /ID# 239415
state: Florida
city: Naples
country: United States
facility: GI Pros /ID# 239486
state: Florida
city: Orlando
country: United States
facility: Central FL Pulmonary Orlando /ID# 245863
state: Florida
city: Nampa
country: United States
facility: Asr, Llc /Id# 239566
state: Idaho
city: Worcester
country: United States
facility: UMass Chan Medical School /ID# 230476
state: Massachusetts
city: Columbia
country: United States
facility: The Curators of the University of Missouri /ID# 233331
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 231633
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College-Pulmonary /ID# 250041
state: New York
city: New York
country: United States
facility: NYU Langone Health /ID# 233417
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health /ID# 229537
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 229511
state: Ohio
city: Cleveland
country: United States
facility: UH Cleveland Medical Center /ID# 246065
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 245864
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, LLC /ID# 239535
state: Oklahoma
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center /ID# 233441
state: Texas
city: San Antonio
country: United States
facility: Univ Texas HSC San Antonio /ID# 239060
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospitals /ID# 239593
state: West Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: