A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)
Condition: Chronic Pancreatitis; Exocrine Pancreatic Insufficiency
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency
Intervention: Placebo; EUR-1008 (APT-1008) High Dose; EUR-1008 (APT-1008) Low Dose
Intervention description: Placebo matching to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which will then be randomized to either high dose or low dose of EUR-1008 (APT-1008).; EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units will be given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.; EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units will be given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Intervention MeSH terms: Pancreatin; Pancrelipase
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Pancreatitis; Exocrine Pancreatic Insufficiency

Summary:

      The primary efficacy objective of this study is to evaluate the difference in coefficient of
      fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low
      dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in
      participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly
      Eurand).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are male or female

          -  Participants with age over 18 years

          -  Participants who have written, legally valid informed consent

          -  Women of childbearing potential must be using a medically acceptable form of birth
             control for the 30 days prior to the beginning of the study and agree to maintain
             adequate birth control measures during the whole duration of the study plus an
             additional 30 days as well as have a negative pregnancy test at screening Visit 3 and
             Visit 7

          -  Participants with documented diagnosis of CP by medical history and it is preferred
             that it is supported by imaging evidence confirming CP which include: abnormal
             endoscopic retrograde cholangio-pancreatography (ERCP) (Cambridge Class 4), abnormal
             computed tomography (CT) scan (dilated main pancreatic duct, atrophy of the pancreas
             or calcification), abnormal ultrasound, or endoscopic ultrasound with at least 5
             abnormalities noted

          -  In the case of pancreatic surgery, the participant can be included with partial or
             distal resection of the pancreas (not due to cancer)

          -  Participants with documented EPI with target fecal elastase (FE) less than or equal to
             100 microgram per gram (mcg/g) of stool using the monoclonal test (pancreatic elastase
             1 [PE1] by Genova Diagnostics) performed at the screening visit. The mean coefficient
             of variation (CV) for the FE test is 20 percent (%)

        Exclusion Criteria:

          -  Participants known to the investigator to have a significant medical and/or mental
             disease that would compromise the participant's welfare, pose an unacceptable risk to
             him/her or confound the study results

          -  Participants who participated in a clinical trial within 30 days of randomization or
             per specific country regulations/guidelines

          -  Participants with cystic fibrosis

          -  Participants with excessive alcohol consumption

          -  Participants with drug abuse

          -  Participants with contraindicated medications or who are unable to discontinue
             prohibited concomitant medication

          -  Participants with uncontrolled diabetes mellitus

          -  Participants allergic to pork protein/unwilling to ingest pork products

          -  Participants with atopic predisposition such as multiple drug hypersensitivity,
             allergic asthma, urticaria, or other relevant allergic diathesis

          -  Participants who are pregnant or lactating

          -  Participants with acute pancreatitis or acute exacerbation in chronic pancreatitis

          -  Participants with acute biliary disease

          -  Participants with malabsorption syndrome caused by a metabolic disease or by surgery,
             not related to exocrine pancreatic insufficiency

          -  Participants with any resection of the stomach or the gastrointestinal tract that will
             affect transit time and/or gastric emptying.

          -  Participants with evidence of active gastric or duodenal ulcer

          -  Participants with chronic inflammatory bowel disease

          -  Participants with any history of pancreatic cancer and other non-cutaneous
             malignancies (except basal cell and squamous cell carcinoma of the skin in situ that
             have been removed and not reoccurred in 5 years)

          -  Participants with viral hepatitis with infectious virions in blood and/or body fluids
             (any etiology)

          -  Participants with human immunodeficiency virus (HIV) infection

          -  Participants with hyperuricemia ( greater than [>] 1.5 times upper normal value for
             lab)

          -  Participants with any acute or chronic disease, which in the opinion of the
             investigator could influence study results or pose a risk to the participants' safety