Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
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
1 other identifier
interventional
30
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2021
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 6, 2021
CompletedStudy Start
First participant enrolled
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2023
CompletedResults Posted
Study results publicly available
July 23, 2024
CompletedJuly 23, 2024
June 1, 2024
1.7 years
September 27, 2021
June 26, 2024
June 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Day 1 (baseline), 8, 15, 29, and 85
Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Day 1 (Baseline), 8, 15, 29, and 85
Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Day 1 (Baseline), 8, 15, 29, and 85
Study Arms (2)
Run-in Period: Creon-ABT
EXPERIMENTALParticipants will receive Creon-ABT daily for 28 days.
Treatment Period: Creon-AAPIS
EXPERIMENTALParticipants will receive Creon-AAPIS daily for 85 days.
Interventions
Capsule; Oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (21)
Velocity Clinical Research /ID# 231076
Mobile, Alabama, 36608-1771, United States
Valley Children's Hospital /ID# 231452
Madera, California, 93636, United States
University of Florida - Archer /ID# 233411
Gainesville, Florida, 32610, United States
Atlantic Medical Research /ID# 239568
Margate, Florida, 33063-5737, United States
University of Miami, Miller School of Medicine /ID# 239415
Miami, Florida, 33136, United States
GI Pros /ID# 239486
Naples, Florida, 34102-5449, United States
Central FL Pulmonary Orlando /ID# 245863
Orlando, Florida, 32803, United States
Asr, Llc /Id# 239566
Nampa, Idaho, 83687, United States
UMass Chan Medical School /ID# 230476
Worcester, Massachusetts, 01655, United States
The Curators of the University of Missouri /ID# 233331
Columbia, Missouri, 65211, United States
Dartmouth-Hitchcock Medical Center /ID# 231633
Lebanon, New Hampshire, 03756, United States
Albany Medical College-Pulmonary /ID# 250041
Albany, New York, 12208-3504, United States
NYU Langone Health /ID# 233417
New York, New York, 10016-2708, United States
Wake Forest Baptist Health /ID# 229537
Winston-Salem, North Carolina, 27157-0001, United States
University of Cincinnati /ID# 229511
Cincinnati, Ohio, 45267-0585, United States
UH Cleveland Medical Center /ID# 246065
Cleveland, Ohio, 44106, United States
Cleveland Clinic Main Campus /ID# 245864
Cleveland, Ohio, 44195, United States
Options Health Research, LLC /ID# 239535
Tulsa, Oklahoma, 74104, United States
Baylor College of Medicine Medical Center /ID# 233441
Houston, Texas, 77030-4202, United States
Univ Texas HSC San Antonio /ID# 239060
San Antonio, Texas, 78229-3901, United States
West Virginia University Hospitals /ID# 239593
Morgantown, West Virginia, 26506, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 6, 2021
Study Start
October 14, 2021
Primary Completion
July 7, 2023
Study Completion
August 28, 2023
Last Updated
July 23, 2024
Results First Posted
July 23, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.