NCT00095732

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

A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	Liprotamase	Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase)
DRUG	Placebo	Administered orally in either Size 2 or Size 5 capsules

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2004-11-09
• Last updated: 2014-10-17

Locations

27 sites across 1 country: United States