An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Diagnosis of cystic fibrosis

• Excessive discharge of fat in feces

• Stable patient requiring pancreatic enzyme therapy

Exclusion Criteria:

• No stable antibiotic therapy for small bowel overgrowth

• No hypersensitivity to pork products

• No use of prokinetics eg, metoclopramide or cisapride within the last 30 days

• No nasogastric feeding tube feeding

• No use of steroids

• No use of concomitant H2 blockers or proton pump inhibitors as concomitant therapy