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

NCT00676702 | Completed Phase 1

• 2 other identifiers: CR014716PNCRLPCYS1001
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis, Chronic; Steatorrhea; Pancreatitis

Keywords

Pancrelipase; PANCREASE MT; Cross-Over Studies; Duodenum; Intestine, Small; Lipase; Amylases; Peptide Hydrolases; Intubation; Safety; Capsules

Outcome Measures

Primary Outcomes (1)

• 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

  Pretreatment and at 15 minute intervals up to 2 hours posttreatment on Day 1 during each treatment period.

Secondary Outcomes (1)

• To evaluate the safety and tolerability of 3 pancrelipase MT 21 capsules containing a total of 63,000 USP units of lipase.

  Time of screening (Day -21) through to the end of the study procedures performed on Day 1 of treatment period 2.

Study Arms (2)

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

002

ACTIVE COMPARATOR

Ensure Plus A high-fat liquid meal of 500 ml of Ensure Plus

Dietary Supplement: Ensure Plus

Interventions

Ensure Plus DIETARY_SUPPLEMENT

A high-fat liquid meal of 500 ml of Ensure Plus

002

Pancrelipase in combination with Ensure Plus DRUG

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.

001

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A study of the enzyme activity and safety of pancrelipase in patients with severe Exocrine Pancreatic Insufficiency (EPI)

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis, Chronic; Steatorrhea; Pancreatitis; Cerebral Palsy

Interventions

Ensure Plus; Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 19, 2011

Record last verified: 2010-02