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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pancreatic Insufficiency, Cystic Fibrosis, Digestive System Diseases, Lung Diseases, Respiratory Tract Diseases

In brief

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

Key facts

Study ID

NCT01710644

Run by

Nordmark Arzneimittel GmbH & Co. KG

People needed

35

Starts

2013-05-01

Expected to finish

2014-08-01

Last updated by the study team

2016-06-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States
• Nemours Children's Clinic — Pensacola, Florida, United States
• The University of Iowa — Iowa City, Iowa, United States
• Via Cristi Hospitals Wichita, Inc. — Wichita, Kansas, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• The Children's Medical Center of Dayton — Dayton, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• West Virginia University Research Corporation — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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