Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms (CisCP)

March 27, 2024 updated by: AbbVie

Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)

Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-2200
        • Stanford University School of Med /ID# 229530
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida - Archer /ID# 227057
    • Maryland
      • Baltimore, Maryland, United States, 21287-0020
        • John Hopkins University /ID# 227061
    • New York
      • New York, New York, United States, 10016-2708
        • NYU Langone Health /ID# 230818
    • Ohio
      • Columbus, Ohio, United States, 43210-1267
        • The Ohio State University Wexner Medical Center /ID# 227844
    • Texas
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine - Baylor Medical Center /ID# 227067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with medical diagnosis of chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI)

Description

Inclusion Criteria:

  • Medical history of chronic pancreatitis (CP).
  • Diagnosis of Exocrine Pancreatic Insufficiency (EPI).

Exclusion Criteria:

--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants on CREON
Drug: CREON
Oral Capsules
Other Names:
  • pancrelipase
  • ABT-SLV245

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire
Time Frame: Up to 1 month
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue
Time Frame: Up to 1 month
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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