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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 27, 2006

Last Updated Date

September 24, 2008

Start Date ^†

February 2006

Current 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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00297167 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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).

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^†

Cystic Fibrosis
Exocrine Pancreatic Insufficiency

Intervention ^†

Drug: Eurand PEP Capsules

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

7 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00297167

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Eurand S.p.A.

Collaborators ^††

Investigators ^†

Principal Investigator:

Rodolfo Amaro Galvez, MD

University of Texas Health Center at Tyler

Information Provided By

Eurand S.p.A.

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.