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

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

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

Drug Information available for:

Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	199/15154, IUMC-9506-10, DIGEST-97-0001-1B
First Received:	July 5, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006063
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

cardiovascular and respiratory diseases

cystic fibrosis

genetic diseases and dysmorphic syndromes

rare disease

Study placed in the following topic categories:

Fibrosis

Respiration Disorders

Rare Diseases

Pancrelipase

Digestive System Diseases

Cystic Fibrosis

Respiratory Tract Diseases

Genetic Diseases, Inborn

Lung Diseases

Pancreatic Diseases

Infant, Newborn, Diseases

Cystic fibrosis

Steatorrhea

Additional relevant MeSH terms:

Pathologic Processes

Therapeutic Uses

Gastrointestinal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Indiana University School of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00006063