Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Pancrelipase Delayed Release (Drug); Placebo Comparator (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Summary
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat
and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
Clinical Details
Official title: A Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Cross-Over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: CFA (Coefficient of Fat Absorption)
Secondary outcome: CNA, stool fat, stool weight, clinical symptomatology (stool frequency, stool consistency, flatulence, abdominal pain)
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- Confirmed PEI by historical CFA < 70% without supplementation or current or historical
fecal elastase < 50µg/g stool (within the last 12 months)
- Subjects of 12 years or older
- Currently receiving treatment with a commercially available pancreatic enzyme product
on a stable dose for more than 3 months
- Clinically stable condition without evidence of acute respiratory disease or any other
acute condition
- Females of child-bearing potential must agree to continue using a medically acceptable
method of birth control
Exclusion Criteria:
- Ileus or acute abdomen
- History of fibrosing colonopathy
- History of distal ileal obstruction syndrome within 6 months of enrollment
- Use of an immunosuppressive drug
- Any type of malignancy involving the digestive tract in the last 5 years
- Known infection with HIV
Locations and Contacts
Site 20, Petrofi, Hungary
Site 21, Jerusalem, Israel
Site 22, Johannesburg, South Africa
Site 23, Barcelona, Spain
Site 10, Los Angeles, California, United States
Site 11, Long Beach, California, United States
Site 13, San Francisco, California, United States
Site 4, Orlando, Florida, United States
Site 5, Miami, Florida, United States
Site 1, Iowa City, Iowa, United States
Site 7, Louisville, Kentucky, United States
Site 17, Boston, Massachusetts, United States
Site 8, Ann Arbor, Michigan, United States
Site 6, Minneapolis, Minnesota, United States
Site 18, Long Branch, New Jersey, United States
Site 16, Albuquerque, New Mexico, United States
Site 2, Toledo, Ohio, United States
Site 12, Dayton, Ohio, United States
Site 19, Cincinnati, Ohio, United States
Site 14, Oklahoma City, Oklahoma, United States
Site 3, Hershey, Pennsylvania, United States
Site 15, Philadelphia, Pennsylvania, United States
Site 9, Nashville, Tennessee, United States
Additional Information
Starting date: November 2007
Ending date: March 2008
Last updated: April 29, 2008
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