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Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT01710644•Nordmark Arzneimittel GmbH & Co. KG

View on ClinicalTrials.gov

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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%

Locations (9)

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

Key Dates

Start Date

May 1, 2013

Primary Completion Date

July 1, 2014

Completion Date

August 1, 2014

Last Updated

June 7, 2016

Enrollment

ACTUAL participants

Conditions

Pancreatic InsufficiencyCystic FibrosisDigestive System DiseasesLung DiseasesRespiratory Tract Diseases

Interventions

Burlulipase

DRUG

Placebo (Caramel in sterile water)

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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