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
Sponsor study identifier
Secondary identifiers
OTHER · Parexel
interventional
35
1 country
9
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2012
Actual (reported)October 19, 2012
Actual (reported)May 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2014
Actual (reported)August 2014
Actual (reported)To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%)
72 hrs
To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI)due to CF, where the primary variable is coefficient of nitrogen absorption (CNA%)
72 hrs
Symptomatology / Symptom Questionnaire
7 days
Burlulipase orally, per meal
Placebo orally, per meal
Burlulipase oral solution will be taken with meals and snacks for 5 to 7 days
Placebo will be taken with meals and snacks for 5 to 7 days
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Nemours Children's Clinic
Pensacola, Florida, 32504, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
Via Cristi Hospitals Wichita, Inc.
Wichita, Kansas, 67214, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
Heubi JE, Schaeffer D, Ahrens RC, Sollo N, Strausbaugh S, Graff G, Jain R, Witte S, Forssmann K. Safety and Efficacy of a Novel Microbial Lipase in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis: A Randomized Controlled Clinical Trial. J Pediatr. 2016 Sep;176:156-161.e1. doi: 10.1016/j.jpeds.2016.05.049. Epub 2016 Jun 11.
Kristin Forssmann, MD
Nordmark Arzneimittel GmbH & Co. KG
James E. Heubi, MD
Children's Hospital Medical Center, Cincinnati
35 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2012
First Posted
October 19, 2012
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
West Virginia University Research Corporation
Morgantown, West Virginia, 26506, United States
Primary Completion
July 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
June 7, 2016
Record last verified: 2016-06
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Source: ClinicalTrials.gov.
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