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Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis Clinical research trials and Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis. Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis clinical trial. Test subjects typically receive the most effective healthcare possible for their Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis  Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Indiana University School of Medicine
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
MaryBrady, Study Chair, Indiana University School of Medicine
Additional Information:
Study ID Numbers: 199/15154; IUMC-9506-10,DIGEST-97-0001-1B
Study Start Date: July 1999
Record last reviewed: July 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006063
Other Cystic Fibrosis Studies:
1. Tissue Collection from People with Cystic Fibrosis
2. Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
3. Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol with Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
4. Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis
5. Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis
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Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
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