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



Status:Completed
Conditions:Gastrointestinal, Pulmonary, Digestive Disease
Therapuetic Areas:Gastroenterology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:5/5/2014
Start Date:May 2013
End Date:April 2014
Contact:Cornelia Breuer
Email:cornelia.breuer@nordmark-pharma.de
Phone:+49-4122-712-0

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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

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


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%
We found this trial at
9
sites
Morgantown, West Virginia 26506
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Cleveland, OH
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1 Childrens Plaza
Dayton, Ohio 45404
(937) 641-3000
Dayton Children's - Dayton We have more than 290,000 reasons to make sure the care...
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Dayton, OH
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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Pensacola, Florida 32504
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Wichita, Kansas 67214
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Wichita, KS
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