Chronic PancreatitisPhase 2NCT02849704

Fat Malabsorption in Chronic Pancreatitis

A Phase 2 study testing Creon36™ in people with Chronic Pancreatitis, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Pancreatitis
What is being tested?: Creon36™
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 13 Oct 2016to 1 Nov 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Chronic pancreatitis diagnosis by gastroenterologist. Participants with CP will be characterized based on the TIGAR-O (toxic, genetic, autoimmune, recurrent, obstructive) etiology system, on pancreatic morphology (Cambridge criteria) when available, and on physiological state (exocrine and endocrine function) as recommended by the recent American Pancreatic Association Practice Guidelines4.
Age 30-70 years old
Evidence of at-risk for malabsorption including: 1) history of use of and response to pancreatic enzyme medication; 2) history of unintentional weight loss; 3) history of increased stools per week or fatty stools; and/or 4) other clinical signs or symptoms suggestive of fat malabsorption
In usual state of health for past two weeks including no change in medications
Able to consume a moderate fat diet for stool evaluations
Able to participate in the study for about four weeks with two study visits

Show all 12Show fewer

Age 30-70 years old
No known chronic disease that would affect dietary intake or fat absorption
In usual state of health for past two weeks, with stable medications, diet and weight
BMI from 18-29
Able to consume a moderate fat diet for stool evaluations
Able to participate in the study for about one week with one study visit

Who cannot join

Evidence of normal fat absorption in medical record
Medications that alter fat absorption (i.e. orlistat, other weight loss medications, ursodeoxycholic acid)
Allergy to pork products
History of intestinal blockage or fibrosing colonopathy
History of gout, kidney disease, or high blood uric acid (hyperuricemia)
Pregnancy or breast feeding

Show all 9Show fewer

Evidence of fat malabsorption
Medications that alter fat absorption (i.e. orlistat, other weight loss medications, ursodeoxycholic acid)
Pregnancy or breast feeding

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Diagnosing Pancreatic-Based Malabsorption in Patients With Chronic Pancreatitis

The objective of this study is to evaluate the malabsorption blood test (MBT), stool coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential screening or diagnostic tests for reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI). A further objective is to determine the test responses before and after pancreatic enzyme medication administration (Creon36™) in the patients with chronic pancreatitis (CP).

Read the detailed description

Reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI) contributes to poor clinical outcome in a number of diseases and conditions. The incidence, mechanism and substantial adverse clinical outcomes of pancreatic insufficiency (PI) are well known in patients with cystic fibrosis (CF), and the life sustaining role of pancreatic enzyme medication in CF care is well established. Much less is known about the incidence and impact of RPF/PI in patients with chronic pancreatitis (CP). Reliable non-invasive screening or diagnostic tests with acceptable patient burden are not available for RPF/PI.

This is a cohort study of subjects with CP who will be evaluated before and after pancreatic enzyme medication (Creon36™) administration. A cohort of healthy subjects will serve as a comparison group and will be evaluated only once.

Subjects with CP will receive Creon36™, a pancreatic enzyme medication, and fat and energy absorption will be evaluated using three methods: MBT, CFA, and BC before and after administration of Creon36™. Many patients with CP are at risk for RPF/PI yet they rarely undergo diagnostic testing. Pancreatic enzyme medication will likely improve clinical outcomes and quality of life in some of those with RPF/PI. A cohort of healthy volunteers will be evaluated with the three methods to provide essential comparison data to optimize the understanding and interpretation of the findings from the three methods and the RPF/PI cohort with CP. There will be no intervention for the healthy cohort.

Conditions: Chronic Pancreatitis
Being tested: Creon36™
Keywords: Chronic Pancreatitis, Pancreatic Function, Reduced Exocrine Pancreatic Function, Pancreatic Insufficiency
Medical subject headings: Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Creon36™Drug
Also called Pancrelipase, CREON
Creon36™ delayed-release capsules, a pancreatic enzyme preparation, is an FDA approved medication. Subjects with chronic pancreatitis (CP) will take Creon36™ for nine days, at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2, the day of Visit 2 and then for five days after the visit until they have completed stool collections.

Study groups in NCT02849704
Study group	Role	What they receive
Chronic Pancreatitis (CP) Subjects	Experimental	CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Subjects will take Creon36™ for 9 days. Subjects will have two study visits, one before and one after treatment initiation with Creon36™. Both visits will be identical with the exception of completion of questionnaires and fecal elastase assessment (only Visit 1). Receives: Drug: Creon36™
Healthy Controls	No intervention	Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects
The fat absorption pattern in CP subjects will be compared with healthy controls. Mean HA AUC will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.
Measured: 8 hours
Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects
The fat absorption pattern in CP subjects will be compared with healthy controls. Mean coefficient of fat absorption (% dietary fat absorbed) will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.
Measured: 72 hours
Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects
The energy absorption pattern in CP subjects will be compared with healthy controls. Mean calories per gram of stool will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the stool energy loss between the two groups.
Measured: 72 hours

Secondary outcomes (3)

Bomb Calorimetry: Difference in Mean Energy Loss Between Groups: Subjects With CP Before and After Creon36™
The energy absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. Calories per gram of stool will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the stool energy loss in the same subjects between the two time points.
Measured: 72 hours
Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Before and After Creon36™
The fat absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. Mean HA AUC will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the fat absorption in the same subjects between the two time points.
Measured: 8 hours
Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Before and After Creon36™
The fat absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. The % of dietary fat absorbed will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the fat absorption in the same subjects between the two time points.
Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 20161 Nov 2017

First posted29 Jul 2016 (estimated)
Study start13 Oct 2016
Primary completion1 Nov 2017
Study completion1 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02849704
Sponsor's protocol ID: 16-013001
Status last verified: Apr 2019
First submitted: 27 Jul 2016
Last updated: 3 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pancreatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnosing Pancreatic-Based Malabsorption in Patients With Chronic Pancreatitis
ClinicalTrials.gov ID: NCT02849704
Acronym / sponsor ID: 16-013001
Conditions: Chronic Pancreatitis
Keywords: Chronic Pancreatitis, Pancreatic Function, Reduced Exocrine Pancreatic Function, Pancreatic Insufficiency
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: AbbVie, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phoenix Indian Medical Center
Study start: 13 Oct 2016 (actual)
Primary completion: 1 Nov 2017 (actual)
Study completion: 1 Nov 2017 (actual)
First posted: 29 Jul 2016 (estimated)
Results: Posted 3 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Chronic Pancreatitis (CP) Subjects	Experimental	Drug: Creon36™CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Subjects will take Creon36™ for 9 days. Subjects will have two study visits, one before and one after treatment initiation with Creon36™. Both visits will be identical with the exception of completion of questionnaires and fecal elastase assessment (only Visit 1).
Healthy Controls	No intervention	–Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Chronic pancreatitis diagnosis by gastroenterologist. Participants with CP will be characterized based on the TIGAR-O (toxic, genetic, autoimmune, recurrent, obstructive) etiology system, on pancreatic morphology (Cambridge criteria) when available, and on physiological state (exocrine and endocrine function) as recommended by the recent American Pancreatic Association Practice Guidelines4.
Age 30-70 years old
Evidence of at-risk for malabsorption including: 1) history of use of and response to pancreatic enzyme medication; 2) history of unintentional weight loss; 3) history of increased stools per week or fatty stools; and/or 4) other clinical signs or symptoms suggestive of fat malabsorption
In usual state of health for past two weeks including no change in medications
Able to consume a moderate fat diet for stool evaluations

Key exclusion criteria (9 listed)

Evidence of normal fat absorption in medical record
Medications that alter fat absorption (i.e. orlistat, other weight loss medications, ursodeoxycholic acid)
Allergy to pork products
History of intestinal blockage or fibrosing colonopathy
History of gout, kidney disease, or high blood uric acid (hyperuricemia)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Creon36™Also: Pancrelipase, CREONCreon36™ delayed-release capsules, a pancreatic enzyme preparation, is an FDA approved medication. Subjects with chronic pancreatitis (CP) will take Creon36™ for nine days, at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2, the day of Visit 2 and then for five days after the visit until they have completed stool collections.	Drug	Chronic Pancreatitis (CP) Subjects

Primary outcome

Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects
Time frame: 8 hours
The fat absorption pattern in CP subjects will be compared with healthy controls. Mean HA AUC will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.
Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects
Time frame: 72 hours
The fat absorption pattern in CP subjects will be compared with healthy controls. Mean coefficient of fat absorption (% dietary fat absorbed) will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.
Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects
Time frame: 72 hours
The energy absorption pattern in CP subjects will be compared with healthy controls. Mean calories per gram of stool will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the stool energy loss between the two groups.

3 secondary outcomes

Bomb Calorimetry: Difference in Mean Energy Loss Between Groups: Subjects With CP Before and After Creon36™
Time frame: 72 hours
Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Before and After Creon36™
Time frame: 8 hours
Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Before and After Creon36™
Time frame: 72 hours

Results and safety

Results posted to the registry on 3 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Pancreatitis (CP) Subjects	11	11
Healthy Controls	0	0

Primary outcome: Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects

Time frame: 8 hours. Mean (Standard Deviation). Unit: mg*h/dL

Measure	Chronic Pancreatitis (CP) Subjects n = 22	Healthy Controls n = 20
Value	8.3 (4.3)	17.7 (10.3)

Chronic Pancreatitis (CP) Subjects vs Healthy Controls: p <0.001, t-test, 2 sided

Population analysed: Two subjects with CP were excluded; one did not complete the study meal for a valid test, and one was a significant outlier calling into question the validity of the test. Of the 24 healthy controls, two were excluded from the study due to undisclosed chronic disease, and two subjects did not complete the study meal for a valid test.

Primary outcome: Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects

Time frame: 72 hours. Mean (Standard Deviation). Unit: % of dietary fat intake

Measure	Chronic Pancreatitis (CP) Subjects n = 20	Healthy Controls n = 22
Value	90.9 (12.8)	95.4 (9.3)

Chronic Pancreatitis (CP) Subjects: p >0.05, t-test, 2 sided

Population analysed: Four subjects with CP were excluded; two did not consume enough fat for a valid test, one subject did not have adequate stool for analysis, and one subject was excluded due to an error in the lab processing stool. Of the 24 healthy controls, two were excluded from the analysis due to undisclosed chronic disease.

Primary outcome: Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects

Time frame: 72 hours. Mean (Standard Deviation). Unit: calories/gram of stool

Measure	Chronic Pancreatitis (CP) Subjects n = 21	Healthy Controls n = 19
Value	5728 (717)	5171 (393)

Chronic Pancreatitis (CP) Subjects vs Healthy Controls: p <0.01, t-test, 2 sided

Population analysed: Three subjects with CP were excluded; two did not consume enough fat for a valid test, one subject did not have adequate stool for analysis. Of the 24 healthy controls, two were excluded from the analysis due to undisclosed chronic disease, one did not provide adequate stool for analysis, and two results failed internal the validation protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the time period during which study procedures were undertaken. For healthy subjects, this includes the 7 days surrounding the assessment visit. For subjects with CP, this includes the 7 days surrounding the baseline assessment visit and the 9 days during which the subjects took Creon surrounding the second assessment visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Pancreatitis (CP) Subjects	0 of 24 (0%)	7 of 24 (29.2%)	0 of 24
Healthy Controls	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Pancreatitis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Babette Zemel, PhD principal investigator

Children's Hospital of Philadelphia

Virginia Stallings, MD study director

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Creon36™ in people with Chronic Pancreatitis, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects (time frame: 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02849704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019; AzTrials last refreshed its copy on 26 Oct 2026.