Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: pancrelipase with bicarbonate (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Mary Sue Brady, Study Chair, Affiliation: Indiana University School of Medicine
Summary
OBJECTIVES:
I. Compare the efficacy of enteric coated pancrelipase with bicarbonate (PANCRECARB)
capsules versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in
decreasing fecal fat and nitrogen losses in patients with cystic fibrosis.
Clinical Details
Study design: Treatment
Detailed description:
PROTOCOL OUTLINE: This is a randomized, multicenter study. In the first treatment period,
patients are randomized to one of two treatment arms.
Arm I: Patients receive enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules
before meals and snacks for 7 consecutive days.
Arm II: Patients receive their usual enteric coated pancreatic enzyme without bicarbonate
capsule before meals and snacks for 7 consecutive days.
Patients receive approximately 50% of their usual lipase dose during treatment. Food intake
is recorded on days 1-3, food intake is weighed and recorded on days 4-7, and stools are
collected over 72 hours on days 5-7 to determine fecal fat and nitrogen excretion.
Anthropometric measurements including height, weight, and skinfolds are assessed.
In the second treatment period, patients are switched to the alternate treatment arm after a
3 day washout period. Patients receive the opposing treatment as per protocol.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
- Clinical diagnosis of cystic fibrosis Duplicate sweat chloride measurements greater
than 60 mEq/L on samples collected after pilocarpine iontophoresis
- Patients with a history of malabsorption who consume at least 1,000 to 2,500 lipase
units/kg/meal
- -Prior/Concurrent Therapy--
- No concurrent oral antibiotics, antacids, H2 receptor antagonists, or any drugs known
to interfere with digestion
- -Patient Characteristics--
- Weight for height greater than the 5th percentile
- No prior meconium ileus with intestinal resection
- No known hypersensitivity to pancrelipase or pork protein
Locations and Contacts
Additional Information
Starting date: July 1999
Ending date: August 1999
Last updated: June 23, 2005
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