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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

February 27, 2006
August 23, 2010
February 2006
November 2006   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00297167 on ClinicalTrials.gov Archive Site
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.
Same as current
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Study to Evaluate the Safety,Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With CF and EPI
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

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Exocrine Pancreatic Insufficiency
Drug: Eurand PEP Capsules
Not Provided
Wooldridge JL, Heubi JE, Amaro-Galvez R, Boas SR, Blake KV, Nasr SZ, Chatfield B, McColley SA, Woo MS, Hardy KA, Kravitz RM, Straforini C, Anelli M, Lee C. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009 Dec;8(6):405-17. Epub 2009 Aug 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297167
EUR-1008-M
Not Provided
Not Provided
Aptalis Pharma
Not Provided
Principal Investigator: Rodolfo Amaro Galvez, MD University of Texas Health Center at Tyler
Aptalis Pharma
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP