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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00676702 |
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 |
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Pancreatitis, Chronic Exocrine Pancreatic Insufficiency Steatorrhea |
Drug: Pancrelipase Microtablet (MT) 20 Other: High-fat liquid meal |
Phase I |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
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001: Experimental |
Drug: Pancrelipase Microtablet (MT) 20
Single dose, 3 capsules (60,000 lipase USP units) with high-fat liquid meal
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002: No Intervention |
Other: High-fat liquid meal
high-fat liquid meal only
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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
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
United States, Florida | |
Recruiting | |
Gainesville, Florida, United States, 32610 |
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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 |
Exocrine pancreatic insufficiency Pancreatitis, chronic Pancrelipase Steatorrhea Adult |
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes Pancreatic Diseases Metabolic disorder |
Intestinal Diseases Pancrelipase Steatorrhea Exocrine Pancreatic Insufficiency Pancreatitis Pancreatitis, Chronic |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |