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Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis

NCT00432861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-02-22

No results posted yet for this study

Summary

The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis and pancreatic insufficiency.

Conditions

Interventions

DRUG

PANCRECARB® (pancrelipase)

Capsules

DRUG

Placebo

Capsules

Sponsors & Collaborators

  • Digestive Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael W Konstan, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432861 on ClinicalTrials.gov