A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the enzyme activity and safety of pancrelipase in patients with severe Exocrine Pancreatic Insufficiency (EPI)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Pancreatin; Pancrelipase; Vitamin K

Criteria

Inclusion Criteria:

• Must have evidence of chronic pancreatitis or pancreatic insufficiency (steatorrhea) confirmed prior to screening

• Must be able to discontinue treatment with any pancreatic enzyme preparations (PEPs) within 72 hours before admission to the study center for the open-label phase to the end-of-study evaluations (a total of approximately 7 days)

• If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and have a negative urine pregnancy test at screening

• Must have signed an informed consent document indicating an understanding of the purpose and procedures required for the study and willingness to participate in the study

Exclusion Criteria:

• Current significant medical and/or mental disease including solid organ transplant, massive small bowel resection, or major gastrointestinal or pancreatic surgery that potentially affect the intestinal absorption and metabolism of fat (excluding severe pancreatic insufficiency with steatorrhea due to chronic pancreatitis or exocrine pancreatic insufficiency)

• History of or current acute pancreatitis or acute exacerbations of chronic pancreatic disease, or coagulopathy

• Use of any prescription that can influence gastrointestinal physiology or any nonprescription medication (including vitamins and herbal supplements) except for acetaminophen, oral contraceptives, and hormonal replacement therapy, and local numbing agents, short-acting benzodiazepines, metoclopramide used during the placement of the intubation tube for up to 3 to 7 days before admission to the study center

• Known allergy to the study drug, pork protein, or any of the excipients of the pancreatic enzyme formulation or to medications used during the placement of the intubation tube (ie, local numbing agents, short-acting benzodiazepines, metoclopramide)

• Unable to swallow solid, oral dosage forms whole with the aid of a liquid meal (participants may not chew, divide, dissolve, or crush the study drug) and/or tolerate gastroduodenal intubation