Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
NCT ID: NCT00006063
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
1999-07-31
1999-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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pancrelipase with bicarbonate
Eligibility Criteria
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Inclusion 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
0 Years
ALL
No
Sponsors
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Indiana University School of Medicine
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Mary Sue Brady
Role: STUDY_CHAIR
Indiana University School of Medicine
Other Identifiers
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IUMC-9506-10
Identifier Type: -
Identifier Source: secondary_id
DIGEST-97-0001-1B
Identifier Type: -
Identifier Source: secondary_id
199/15154
Identifier Type: -
Identifier Source: org_study_id