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

NCT00775528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2010-11-08

Study results available
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Summary

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

Conditions

Interventions

DRUG

Pancrelipase Delayed Release

3,000, 6,000 and 12,000 unit Lipase Capsules

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

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 NCT00775528 on ClinicalTrials.gov