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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordmark Arzneimittel GmbH & Co. KG
• Collaborator: Parexel

Criteria

Inclusion Criteria:

• Male and female patients aged ≥12 years from the date of informed consent

• Confirmed diagnosis of CF at screening

• Confirmed EPI by historical (within past 12 months) CFA <70% without use of PERTs or current fecal elastase <50 µg/g stool at screening

• Currently receiving PERT with a commercially available pancreatic enzyme

• Currently on stable treatment with proton pump inhibitors or H2 receptor antagonists

• Clinically stable condition without evidence of acute respiratory disease or any other acute condition

Exclusion Criteria:

• History of fibrosing colonopathy

• History of significant bowel resection, in the opinion of the investigator, or solid organ transplant

• History of being refractory to pancreatic enzyme replacement

• Current diagnosis or history of distal intestinal obstruction syndrome

• Current diagnosis of small intestinal bacterial overgrowth, ileus or acute abdomen

• A body mass index percentile <10%