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

Primary Purpose

Cystic Fibrosis, Chronic Pancreatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CREON
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Velocity Clinical Research /ID# 231076
  • University of Florida - Archer /ID# 233411
  • Atlantic Medical Research Group /ID# 239568
  • University of Miami, Miller School of Medicine /ID# 239415
  • GI Pros /ID# 239486
  • Central FL Pulmonary Orlando /ID# 245863
  • Asr, Llc /Id# 239566
  • UMass Chan Medical School /ID# 230476
  • The Curators of the University of Missouri /ID# 233331
  • Dartmouth-Hitchcock Medical Center /ID# 231633
  • Albany Medical College-Pulmonary /ID# 250041
  • NYU Langone Health /ID# 233417
  • Wake Forest Baptist Health /ID# 229537
  • University of Cincinnati /ID# 229511
  • UH Cleveland Medical Center /ID# 246065
  • Cleveland Clinic Main Campus /ID# 245864
  • Options Health Research, LLC /ID# 239535
  • Baylor College of Medicine Medical Center /ID# 233441
  • Univ Texas HSC San Antonio /ID# 239060
  • West Virginia University Hospitals /ID# 239593

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Run-in Period: Creon

Treatment Period: Creon

Arm Description

Participants will receive Creon daily for 112 days.

Participants will receive Creon daily for 112 days.

Outcomes

Primary Outcome Measures

Symptoms of Exocrine Pancreatic Insufficiency (EPI)
Mean symptom scores will be summarized.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
September 14, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05069597
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
July 7, 2023 (Actual)
Study Completion Date
August 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Chronic Pancreatitis
Keywords
Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Run-in Period: Creon
Arm Type
Experimental
Arm Description
Participants will receive Creon daily for 112 days.
Arm Title
Treatment Period: Creon
Arm Type
Experimental
Arm Description
Participants will receive Creon daily for 112 days.
Intervention Type
Drug
Intervention Name(s)
CREON
Other Intervention Name(s)
Pancrelipase
Intervention Description
Capsule; Oral
Primary Outcome Measure Information:
Title
Symptoms of Exocrine Pancreatic Insufficiency (EPI)
Description
Mean symptom scores will be summarized.
Time Frame
Day 1 through Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research /ID# 231076
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-1771
Country
United States
Facility Name
University of Florida - Archer /ID# 233411
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Atlantic Medical Research Group /ID# 239568
City
Margate
State/Province
Florida
ZIP/Postal Code
33063-5737
Country
United States
Facility Name
University of Miami, Miller School of Medicine /ID# 239415
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GI Pros /ID# 239486
City
Naples
State/Province
Florida
ZIP/Postal Code
34102-5449
Country
United States
Facility Name
Central FL Pulmonary Orlando /ID# 245863
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Asr, Llc /Id# 239566
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
UMass Chan Medical School /ID# 230476
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
The Curators of the University of Missouri /ID# 233331
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 231633
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albany Medical College-Pulmonary /ID# 250041
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3504
Country
United States
Facility Name
NYU Langone Health /ID# 233417
City
New York
State/Province
New York
ZIP/Postal Code
10016-2708
Country
United States
Facility Name
Wake Forest Baptist Health /ID# 229537
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
University of Cincinnati /ID# 229511
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
UH Cleveland Medical Center /ID# 246065
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 245864
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Options Health Research, LLC /ID# 239535
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Baylor College of Medicine Medical Center /ID# 233441
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4202
Country
United States
Facility Name
Univ Texas HSC San Antonio /ID# 239060
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3901
Country
United States
Facility Name
West Virginia University Hospitals /ID# 239593
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info

Learn more about this trial

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

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