Study Investigating a Delayed-Release Pancrelipase in Patients With PEI Due to CF
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Pancreatic Exocrine Insufficiency
Intervention: Pancrelipase Delayed Release (Drug); Placebo Comparator (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Overall contact:
Djenane Bennett, Email: djenane.bennet@solvay.com
Summary
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat
and nitrogen absorption in subjects 7 - 11 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 12,000 Unit Capsules in Subjects Aged 7 - 11 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
Secondary outcome: CNA (coefficient of nitrogen absorption), stool fat, stool weight, clinical symptomatology (stool frequency, stool consistency, flatulence, abdominal pain)
Eligibility
Minimum age: 7 Years.
Maximum age: 11 Years.
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/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
- Stable body weight and agrees to abstain from sexual activity
Exclusion Criteria:
- Ileus or acute abdomen
- History of fibrosing colonopathy, celiac disease, gastrectomy, crohn´s disease and
small bowel surgery other than minor resection due to meconium ileus without resulting
in malabsorption syndrome
- 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
Djenane Bennett, Email: djenane.bennet@solvay.com
Site 2, Iowa City, Iowa, United States; Recruiting
Site 5, Louisville, Kentucky, United States; Recruiting
Site 9, Boston, Massachusetts, United States; Recruiting
Site 6, Ann Arbor, Michigan, United States; Recruiting
Site 4, Minneapolis, Minnesota, United States; Recruiting
Site 8, Albuquerque, New Mexico, United States; Recruiting
Site 1, Cincinnati, Ohio, United States; Recruiting
Site 7, Oklahoma City, Oklahoma, United States; Recruiting
Site 10, Oklahoma City, Oklahoma, United States; Not yet recruiting
Site 3, Hershey, Pennsylvania, United States; Recruiting
Additional Information
Starting date: June 2008
Ending date: December 2008
Last updated: October 23, 2008
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