CisCP: Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04949828
Collaborator
(none)
90
8
11.5
11.3
1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)
Actual Study Start Date
:
Sep 16, 2021
Anticipated Primary Completion Date
:
Aug 31, 2022
Anticipated Study Completion Date
:
Aug 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants on CREON
|
Drug: CREON
Oral Capsules
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire [Up to 1 month]
Secondary Outcome Measures
- Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue [Up to 1 month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Med /ID# 229530 | Stanford | California | United States | 94305-2200 |
| 2 | University of Florida - Archer /ID# 227057 | Gainesville | Florida | United States | 32610 |
| 3 | John Hopkins University /ID# 227061 | Baltimore | Maryland | United States | 21287-0020 |
| 4 | University of Minnesota - Minneapolis /ID# 227364 | Minneapolis | Minnesota | United States | 55455-0341 |
| 5 | NYU Langone Health /ID# 230818 | New York | New York | United States | 10016-2708 |
| 6 | Duke University Hospital /ID# 227065 | Durham | North Carolina | United States | 27710 |
| 7 | The Ohio State University Wexner Medical Center /ID# 227844 | Columbus | Ohio | United States | 43210-1267 |
| 8 | Baylor College of Medicine - Baylor Medical Center /ID# 227067 | Houston | Texas | United States | 77030-3411 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT04949828
Other Study ID Numbers:
- P20-238
First Posted:
Jul 2, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by AbbVie
Additional relevant MeSH terms: