drugset
drugset / Trial / NCT00981214

Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

NCT00981214 ↗

Phase 3 Completed 19 enrolled Forest Laboratories
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

Timeline

Start
2006-05
Primary completion
2006-09
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 10000 iu/kg Oral

Indications

cystic fibrosis exocrine pancreatic insufficiency