MedTrace Logo

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

NCT01710644 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-06-07

No results posted yet for this study

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

Conditions

  • Pancreatic Insufficiency
  • Cystic Fibrosis
  • Digestive System Diseases
  • Lung Diseases
  • Respiratory Tract Diseases

Interventions

DRUG

Burlulipase

Burlulipase oral solution will be taken with meals and snacks for 5 to 7 days

DRUG

Placebo (Caramel in sterile water)

Placebo will be taken with meals and snacks for 5 to 7 days

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Nordmark Arzneimittel GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Kristin Forssmann, MD · Nordmark Arzneimittel GmbH & Co. KG

  • James E. Heubi, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710644 on ClinicalTrials.gov