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Study to Evaluate the Safety,Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With CF and EPI

This study has been completed.
Sponsor:
Information provided by:
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT00297167
First received: February 27, 2006
Last updated: August 23, 2010
Last verified: August 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: 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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Aptalis Pharma:

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
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  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
Aptalis Pharma
Investigators
Principal Investigator: Rodolfo Amaro Galvez, MD University of Texas Health Center at Tyler
  More Information

No publications provided by Aptalis Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00297167     History of Changes
Other Study ID Numbers: EUR-1008-M
Study First Received: February 27, 2006
Last Updated: August 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Aptalis Pharma:
CF
Cystic Fibrosis
EPI
Exocrine Pancreatic Insufficiency
 Pancreatic
Enzyme
PEP

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013