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

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Indiana University School of Medicine

Investigators

  • Study Chair: Mary Sue Brady, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Completion

August 1, 1999

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

July 5, 2000

First Posted (Estimate)

July 6, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15154
  • IUMC-9506-10
  • DIGEST-97-0001-1B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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