Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NCT ID: NCT01710644
Last Updated: 2016-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
35 participants
INTERVENTIONAL
2013-05-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Burlulipase
Burlulipase orally, per meal
Burlulipase
Burlulipase oral solution will be taken with meals and snacks for 5 to 7 days
Placebo (Caramel in sterile water)
Placebo orally, per meal
Placebo (Caramel in sterile water)
Placebo will be taken with meals and snacks for 5 to 7 days
Interventions
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Burlulipase
Burlulipase oral solution will be taken with meals and snacks for 5 to 7 days
Placebo (Caramel in sterile water)
Placebo will be taken with meals and snacks for 5 to 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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%
12 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Nordmark Arzneimittel GmbH & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Kristin Forssmann, MD
Role: STUDY_DIRECTOR
Nordmark Arzneimittel GmbH & Co. KG
James E. Heubi, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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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
Countries
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References
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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.
Other Identifiers
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207862
Identifier Type: OTHER
Identifier Source: secondary_id
NM-BL-101
Identifier Type: -
Identifier Source: org_study_id
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