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Safety and Maintenance Study of Entocort for Children With Crohn's Disease

NCT01453946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-01-06

Study results available
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Summary

A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

Conditions

Interventions

DRUG

Entocort

Entocort capsules, taken orally, 6 mg daily.

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Principal Investigators

  • Stanley Cohen, MD · Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA

  • Stefan Eklund, MD · AstraZeneca Pharmaceuticals, Mölndal, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Poland

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 NCT01453946 on ClinicalTrials.gov