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

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00676702

Purpose

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

Condition	Intervention	Phase
Exocrine Pancreatic Insufficiency Pancreatitis, Chronic Steatorrhea Pancreatitis	Dietary Supplement: Ensure Plus Drug: Pancrelipase in combination with Ensure Plus	Phase I

Study Type:	Interventional
Study Design:	Crossover Assignment, Pharmacokinetics Study
Official Title:	A Single-Dose, Open-Label, Randomized, Crossover Study to Evaluate Intraduodenal Enzyme Delivery of PANCREASE MT in Subjects With Severe Exocrine Pancreatic Insufficiency

Resource links provided by NLM:

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

To evaluate the pharmacokinetics (enzyme activity) of intraduodenal enzyme (lipase, amylase, and protease) delivery of a single dose of 3 pancrelipase MT 21 capsules in gastric and duodenal fluid samples collected from patients [ Time Frame: Pretreatment and at 15 minute intervals up to 2 hours posttreatment on Day 1 during each treatment period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of 3 pancrelipase MT 21 capsules containing a total of 63,000 USP units of lipase. [ Time Frame: Time of screening (Day -21) through to the end of the study procedures performed on Day 1 of treatment period 2. ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	July 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental Pancrelipase in combination with Ensure Plus 3 pancrelipase MT 21 capsules containing a total of 63 000 USP units of lipase with a high-fat liquid meal of 500 ml of Ensure Plus.	Drug: Pancrelipase in combination with Ensure Plus 3 pancrelipase MT 21 capsules containing a total of 63,000 USP units of lipase with a high-fat liquid meal of 500 ml of Ensure Plus.
002: Active Comparator Ensure Plus A high-fat liquid meal of 500 ml of Ensure Plus	Dietary Supplement: Ensure Plus A high-fat liquid meal of 500 ml of Ensure Plus

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Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676702

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

A study of the enzyme activity and safety of pancrelipase in patients with severe Exocrine Pancreatic Insufficiency (EPI) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Senior Director Clinical Research and Development )
Study ID Numbers:	CR014716, PNCRLPCYS1001
Study First Received:	May 8, 2008
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00676702 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Pancrelipase
PANCREASE MT
Cross-Over Studies
Duodenum
Intestine, Small
Lipase

Amylases
Peptide Hydrolases
Intubation
Safety
Capsules

Additional relevant MeSH terms:

Metabolic Diseases
Gastrointestinal Diseases
Gastrointestinal Agents
Intestinal Diseases
Pancrelipase
Pharmacologic Actions
Digestive System Diseases

Therapeutic Uses
Pancreatic Diseases
Malabsorption Syndromes
Exocrine Pancreatic Insufficiency
Pancreatitis
Steatorrhea
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on February 08, 2010