Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
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)
Phase: Phase 3
Status: Not yet 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.bennett@solvay.com
Summary
This study will assess the safety and tolerability of pancrelipase delayed release capsules
in subjects up to 6 years of age with PEI due to Cystic Fibrosis.
Clinical Details
Official title: An Open Label, Multi-Center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children up to 6 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Clinical SymptomatologyAdverse Events Vital Signs
Eligibility
Minimum age: 1 Month.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- Current or historical human fecal elastase < 50µg/gstool
- Weight greater than 3. 75 kg
- Age 1 month to 6 years
- 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
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.bennett@solvay.com
Site 11, Boise, Idaho, United States
Site 2, Iowa City, Iowa, United States
Site 5, Louisville, Kentucky, United States
Site 9, Boston, Massachusetts, United States
Site 6, Ann Arbor, Michigan, United States
Site 12, Detroit, Michigan, United States
Site 4, Minneapolis, Minnesota, United States
Site 13, Long Branch, New Jersey, United States
Site 8, Albuquerque, New Mexico, United States
Site 1, Cincinnati, Ohio, United States
Site 7, Oklahoma City, Oklahoma, United States
Site 10, Oklahoma City, Oklahoma, United States
Site 3, Hershey, Pennsylvania, United States
Additional Information
Starting date: January 2009
Ending date: August 2009
Last updated: October 17, 2008
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