NCT01710644

Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Nordmark Arzneimittel GmbH & Co. KG · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis

Conditions

• Pancreatic Insufficiency
• Cystic Fibrosis
• Digestive System Diseases
• Lung Diseases
• Respiratory Tract Diseases

Interventions

Type	Name	Description
DRUG	Burlulipase	Burlulipase oral solution will be taken with meals and snacks for 5 to 7 days
DRUG	Placebo (Caramel in sterile water)	Placebo will be taken with meals and snacks for 5 to 7 days

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2012-10-19
• Last updated: 2016-06-07

Locations

9 sites across 1 country: United States