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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2016 |
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Main ID: |
NCT01710644 |
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Date of registration:
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17/10/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
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Scientific title:
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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 |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01710644 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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James E. Heubi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Name:
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Kristin Forssmann, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nordmark Arzneimittel GmbH & Co. KG |
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Key inclusion & exclusion criteria
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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%
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Digestive System Diseases
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Cystic Fibrosis
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Respiratory Tract Diseases
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Pancreatic Insufficiency
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Lung Diseases
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Intervention(s)
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Drug: Burlulipase
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Drug: Placebo (Caramel in sterile water)
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Primary Outcome(s)
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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%)
[Time Frame: 72 hrs]
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Secondary Outcome(s)
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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%)
[Time Frame: 72 hrs]
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Secondary ID(s)
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NM-BL-101
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207862
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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