Text Size

A Safety and Efficacy Study on ULTRASE MT20 in Patients With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)

This study has been completed.
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00408317
First received: December 4, 2006
Last updated: August 7, 2007
Last verified: August 2007
History of Changes
  Purpose

Cystic Fibrosis (CF) is a genetic disease resulting from the inheritance of a defective autosomal recessive gene. It often results in exocrine pancreatic insufficiency (PI) that leads to non-digestion of fats and proteins and finally to malabsorption of these nutrients. The patients need to take pancreatic enzymes to allow absorption of these nutriments and this has contributed to a significant increase in the life span of CF patients.

The purpose of this study is to assess the safety and efficacy of ULTRASE MT20 compared to placebo for the correction of fat and protein malabsorption in patients with CF and PI.


Condition Intervention Phase
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
 Drug: ULTRASE MT20
 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 Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of ULTRASE MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF).

Resource links provided by NLM:

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

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • Compare the coefficient of fat absorption (CFA) of ULTRASE MT20 to placebo. The CFA will be measured by assessing the dietary fat intake and excretion during a 72-hour period.

Secondary Outcome Measures:
  • Compare the coefficient of protein absorption (CNA) of ULTRASE MT20 to placebo. The CNA will be measured as the CFA. The safety will be evaluated from the laboratory analyses, the adverse events and the overall signs and symptoms.

Enrollment: 37
Study Start Date: November 2006
Study Completion Date: April 2007
  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 Cystic Fibrosis
  • Patients must have pancreatic insufficiency and must require pancreatic enzyme supplementation
  • Patients must be 7 years and older
  • Patients must be on an optimal clinical dose of pancreatic enzymes and must be clinically stable
  • Patients must have an adequate nutritional status

Key Exclusion Criteria:

  • Patients with acute pancreatitis or acute exacerbation of chronic pancreatic disease
  • Patients with an acute pulmonary infection
  • Patients with a history of bowel resection
  • Patients suffering from any dysmotility disorders
  • Patients with chronic or severe abdominal pain
  • Patients known to have a significant medical disease that would compromise their welfare or confound the study results
  • Patients with a history of or a current diagnosis of clinically significant portal hypertension
  • Patients who have a condition known to increase fecal fat loss
  • Patients with a current diagnosis or a history of complete DIOS
  • Patients with poorly controlled diabetes
  • Female patients who are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408317

Locations
United States, Michigan
DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
United States, Ohio
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Pennsylvania State University, The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Axcan Pharma
Investigators
Principal Investigator: Michael W Konstan, MD Rainbow Babies & Children's Hospital, Cleveland, Ohio
Study Director: Jean Spénard, Ph.D. Axcan Pharma Inc., Mont-St-Hilaire, Québec, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00408317     History of Changes
Other Study ID Numbers: UMT20CF05-01
Study First Received: December 4, 2006
Last Updated: August 7, 2007
Health Authority: United States: Food and Drug Administration

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
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013