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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00217204 |
The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers
Condition | Intervention | Phase |
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Steatorrhea Cystic Fibrosis |
Drug: pancrelipase |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption |
Estimated Enrollment: | 20 |
Study Start Date: | July 2005 |
Study Completion Date: | February 2006 |
The objective of this randomized, Investigator-blinded, parallel group, multicenter, pilot study is to evaluate the preliminary safety, palatability and effectiveness of pancrelipase microtablets to improve fat absorption. The hypothesis is that PANCREASE MT will provide effective, safe and palatable pancreatic enzyme supplementation to be used for the treatment of fat malabsorption in a cohort of infants with cystic fibrosis-related pancreatic insufficiency. On Day 1 of the study, parents will be instructed to administer 500 units lipase/kg/meal for a full five days. Stool will be collected and analyzed during the last 72 hours of this baseline period. On Day 6 of the study, subjects will be randomly assigned to one of four treatment groups. Parents will be instructed to administer the appropriate dose for a full five days and stool will be collected and analyzed during the last 72 hours of this randomized treatment period.
Patients will receive PANCREASE MT 500 units lipase/kg/meal by mouth for a maximum of five doses per day for the first 120 hours. Patients will receive PANCREASE MT 500, 1000, 1500 or 2000 units lipase/kg/meal by mouth, for a maximum of five meals per day for the next 120 hours.
Ages Eligible for Study: | 6 Months to 30 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR002665 |
Study First Received: | September 13, 2005 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00217204 |
Health Authority: | United States: Institutional Review Board |
Fat malabsorption Pancreatic insufficiency Cystic fibrosis Steatorrhea Pancrelipase |
Metabolic Diseases Fibrosis Gastrointestinal Diseases Intestinal Diseases Pancrelipase Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn |
Lung Diseases Malabsorption Syndromes Pancreatic Diseases Infant, Newborn, Diseases Metabolic disorder Cystic fibrosis Exocrine Pancreatic Insufficiency Steatorrhea |
Pathologic Processes Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |