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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach

1 country

6 active sites

Status

completed

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

2.5 years study duration

First Submitted

Initial submission to the registry

June 21, 2021

Completed

11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed

Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

2.5 years

First QC Date

June 21, 2021

Last Update Submit

March 27, 2024

Conditions

Chronic Pancreatitis

Keywords

Chronic pancreatitisExocrine Pancreatic InsufficiencyCREONpancrelipaseABT-SLV245

Outcome Measures

Primary Outcomes (1)

Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire
Up to 1 month

Secondary Outcomes (1)

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

Study Arms (1)

Participants on CREON

Drug: CREON

Interventions

CREONDRUG

Oral Capsules

Also known as: pancrelipase, ABT-SLV245

Participants on CREON

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

AbbVielead

Study Sites (6)

Stanford University School of Med /ID# 229530

Stanford, California, 94305-2200, United States

Location

University of Florida - Archer /ID# 227057

Gainesville, Florida, 32610, United States

Location

John Hopkins University /ID# 227061

Baltimore, Maryland, 21287-0020, United States

Location

NYU Langone Health /ID# 230818

New York, New York, 10016-2708, United States

Location

The Ohio State University Wexner Medical Center /ID# 227844

Columbus, Ohio, 43210-1267, United States

Location

Baylor College of Medicine - Baylor Medical Center /ID# 227067

Houston, Texas, 77030-3411, United States

Location

MeSH Terms

Conditions

Pancreatitis, ChronicExocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Officials

ABBVIE INC.
AbbVie
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 2, 2021

Study Start

September 16, 2021

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations

US(6)

Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Participants on CREON

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Participants on CREON

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations