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Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006063
First Posted: July 6, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Indiana University School of Medicine
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

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.


Condition Intervention
Cystic Fibrosis Drug: pancrelipase with bicarbonate

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 24
Study Start Date: July 1999
Estimated Study Completion Date: August 1999
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006063


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Indiana University School of Medicine
Investigators
Study Chair: Mary Sue Brady Indiana University School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00006063     History of Changes
Other Study ID Numbers: 199/15154
IUMC-9506-10
DIGEST-97-0001-1B
First Submitted: July 5, 2000
First Posted: July 6, 2000
Last Update Posted: December 9, 2005
Last Verified: July 2000

Keywords provided by Office of Rare Diseases (ORD):
cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents