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Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients

NCT00663975 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-05-13

No results posted yet for this study

Summary

Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients \<= 2 years of age.

The results of this study are intended to be submitted to the FDA as part of the NDA package for marketing approval of PANCRECARB (DCI 1020).

Conditions

  • Digestive System Diseases
  • Pancreatic Disease
  • Cystic Fibrosis
  • Exocrine Pancreatic Insufficiency

Interventions

DRUG

DCI 1020

capsules (4,000 units of lipase) will be administered with meals and snacks

Sponsors & Collaborators

  • Digestive Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Tibor Sipos, PhD · DCI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-08-31
Completion
2009-11-30

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 NCT00663975 on ClinicalTrials.gov