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An Open-Label Study of Intraduodenal Enzyme Delivery of Pancrelipase Microtablets (MT) in Patients With Severe Exocrine Pancreatic Insufficiency
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., November 2008
Sponsored by: 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 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.


Condition Intervention Phase
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Steatorrhea
Drug: Pancrelipase Microtablet (MT) 20
Other: High-fat liquid meal
Phase I

Drug Information available for: Pancrelipase Ultrase Lipase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability 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

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

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2008
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
001: Experimental Drug: Pancrelipase Microtablet (MT) 20
Single dose, 3 capsules (60,000 lipase USP units) with high-fat liquid meal
002: No Intervention Other: High-fat liquid meal
high-fat liquid meal only

Detailed Description:

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

  Eligibility

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676702

Contacts
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

Locations
United States, Florida
Recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Senior Director, Compound Development Team Leader )
Study ID Numbers: CR014716
Study First Received: May 8, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00676702  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Exocrine pancreatic insufficiency
Pancreatitis, chronic
Pancrelipase
Steatorrhea
Adult

Study placed in the following topic categories:
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes
Pancreatic Diseases
Metabolic disorder
Intestinal Diseases
Pancrelipase
Steatorrhea
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic

Additional relevant MeSH terms:
Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009