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Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

NCT00510484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2010-06-03

Study results available
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Summary

This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.

Conditions

Interventions

DRUG

Pancrelipase Delayed Release

24000 unit Capsule

DRUG

Placebo Comparator

Placebo

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Hungary
  • Israel
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

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 NCT00510484 on ClinicalTrials.gov