A Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

This study has been completed.

First Received: February 27, 2006 Last Updated: September 24, 2008 History of Changes

Sponsored by:	Eurand S.p.A.
Information provided by:	Eurand S.p.A.
ClinicalTrials.gov Identifier:	NCT00297167

Purpose

The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Eurand PEP capsules or placebo in patients with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

Condition	Intervention	Phase
Cystic Fibrosis Exocrine Pancreatic Insufficiency	Drug: Eurand PEP Capsules	Phase III

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Crossover Assignment, Double-Blind, Placebo Control, Randomized, Safety/Efficacy Study, Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

Further study details as provided by Eurand S.p.A.:

Primary Outcome Measures:

Compare the coefficient of fat absorption (CFA) following oral administration of Eurand PEP capsules or placebo; safety objectives will concentrate on the frequency, duration, and severity of treatment emergent, adverse events (AEs) and

Secondary Outcome Measures:

Compare changes in the coefficient of nitrogen absorption (CNA), cholesterol, fat-soluble vitamins, weight, body mass index (BMI), and symptoms of EPI after the oral administration of Eurand PEP capsules and placebo.

Estimated Enrollment:	30
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	7 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

confirmed diagnosis of CF
confirmed diagnosis of EPI: currently receiving treatment with a commercially available pancreatic enzyme product
clinically stable with no evidence of acute respiratory disease or any other acute condition

Key Exclusion Criteria:

fibrosing colonopathy - hyperuricemia or hyperuricosuria
allergy to pork or other porcine PEPs
abdominal or small bowel resection
a history of or current diagnosis of distal ileal obstruction syndrome (DIOS)
solid organ transplant or surgery affecting the bowel
use of an immunosuppressive drug
breastfeeding or pregnant
any condition that would, in the investigator's opinion, limit the patient's ability to complete the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297167

Locations

United States, Texas
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708

Sponsors and Collaborators

Eurand S.p.A.

Investigators

Principal Investigator:

Rodolfo Amaro Galvez, MD

University of Texas Health Center at Tyler

More Information

No publications provided

Study ID Numbers:	EUR-1008-M
Study First Received:	February 27, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00297167 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eurand S.p.A.:

CF
Cystic Fibrosis
Enzyme
EPI

EPI
Exocrine Pancreatic Insufficiency
Pancreatic
PEP

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Exocrine Pancreatic Insufficiency

ClinicalTrials.gov processed this record on March 16, 2009