drugset
drugset / Trial / NCT00095732

Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

NCT00095732 ↗

Phase 2 Completed 129 enrolled Anthera Pharmaceuticals Cystic Fibrosis Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.

Timeline

Start
2004-06
Primary completion
2005-03
Completion
2005-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Liprotamase Protein / enzyme biologic 5000 iu Oral
Subject Liprotamase Protein / enzyme biologic 25000 iu Oral
Subject Liprotamase Protein / enzyme biologic 100000 iu Oral

Indications

cystic fibrosis exocrine pancreatic insufficiency