MedTrace Logo

Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

NCT01641393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-03-14

No results posted yet for this study

Summary

The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.

Conditions

  • Exocrine Pancreatic Insufficiency: Cystic Fibrosis

Interventions

DRUG

EUR-1008 25,000 Units

EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18 Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity. Each capsule contains approximately 25,000 Ph. Eur. lipase units. EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.

DRUG

Kreon 25,000 Units

Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18 Each capsule contains approximately 25,000 Ph. Eur. lipase units. Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Christopher Taylor, MD, PhD · Sheffield Children's Hospital, The Academic Unit of Child Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Belgium
  • Bulgaria
  • France
  • Germany
  • Italy
  • Poland
  • United Kingdom

Study Locations

More Related Trials

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 NCT01641393 on ClinicalTrials.gov