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”

The purpose of this study is to evaluate the delivery of enzyme (lipase, amylase, and protease) into the duodenum from a single dose of pancrelipase MT in patients with severe pancreatic insufficiency and presence fat in stools (steatorrhea). In addition, safety and tolerability will be assessed.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study

This is a single-dose, open-label, randomized, 2-way crossover study of pancrelipase MT. The study consists of a screening phase and an open label treatment phase (2 treatment phases).

In the screening phase, patients will undergo screening procedures prior to entry into the study and will be instructed to stop taking their existing pancreatic enzyme supplement, if applicable, for 72 hours before admission into the study center for the open-label phase. In the open-label phase, the patient will participate in both treatment phases in random order.

In each treatment phase, patients will be intubated with a Dreiling-like tube and receive a treatment (a high-fat liquid meal or 3 pancrelipase MT20 capsules administered with a high-fat liquid meal). Duodenal and gastric samples will be collected with the tube. There is 1-day resting period between the 2 treatment phases. Safety and tolerability will be assessed by adverse events; laboratory tests, including hematology, serum chemistry, and urinalysis; vital sign measurements, including oral temperature, heart and respiratory rates, and blood pressure.

3 pancrelipase MT20 capsules (total of 60,000 U.S.P. units of lipase), oral administration simultaneously with a high-fat liquid meal

Intervention(s) in this Clinical Trial

• Drug: Pancrelipase Microtablet (MT) 20
  • Single dose, 3 capsules (60,000 lipase USP units) with high-fat liquid meal
• Other: High-fat liquid meal
  • high-fat liquid meal only

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
• No Intervention: 002

Primary Measures

• Evaluation of the Intraduodenal Lipase activity following administration of pancrelipase MT20 capsules with a high-fat liquid meal
  • Time Frame: Evaluation of the Intraduodenal Lipase activity following administration of pancrelipase MT20 capsules with a high-fat liquid meal
    Safety Issue?: No

Secondary Measures

• Evaluation of the Intraduodenal Amylase and Protease activities following administration of pancrelipase MT20 capsules with a high-fat liquid meal
  • Time Frame: Evaluation of the Intraduodenal Amylase and Protease activities following administration of pancrelipase MT20 capsules with a high-fat liquid meal
    Safety Issue?: No

Inclusion Criteria:

• Have evidence and confirmation of severe pancreatic insufficiency with steatorrhea due to chronic pancreatitis or exocrine pancreatic insufficiency of other etiology
• Must be off existing pancreatic enzyme supplement prior to admission into the study center for the open-label phase
• If female, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control and must have a negative urine pregnancy test at screening

Exclusion Criteria:

• No history of or current acute pancreatitis, acute exacerbations of chronic pancreatic disease, coagulopathy, solid organ transplant or massive small bowel resection
• No known allergy to the study drug, pork protein, or any of the excipients of the pancreatic enzyme formulation
• 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)
• Unable to tolerate or have contraindication to gastroduodenal intubation
• No history of major gastrointestinal or pancreatic surgery that potentially affect the intestinal absorption and metabolism of fat (e.g. Whipple's procedure)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Overall Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:  info1@veritasmedicine.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00676702

Study ID Number: CR014716

ClinicalTrials.gov Identifier: NCT00676702

Health Authority: United States: Food and Drug Administration

To learn how to participate in this trial please click here.