Safety Study of Entocort for Children With Crohn's Disease

January 4, 2022 updated by: Padagis LLC

A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
  • Germany
      • München, Germany
        • Research Site
  • Italy
      • Firenze, Italy
        • Research Site
      • Messina, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
  • Poland
      • Kraków, Poland
        • Research Site
      • Rzeszów, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wrocław, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
  • United States
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Oak Lawn, Illinois, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Minnesota
      • Saint Paul, Minnesota, United States
        • Research Site
    • New Jersey
      • Mays Landing, New Jersey, United States
        • Research Site
      • Morristown, New Jersey, United States
        • Research Site
    • New York
      • Buffalo, New York, United States
        • Research Site
    • North Carolina
      • Greenville, North Carolina, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit.
  • Subject must be diagnosed with active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology.
  • Subjects with mild to moderate Crohn's disease.
  • All subjects must have a stool analysis negative for Clostridium difficile toxin, Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days prior to visit 1.
  • All subjects must have had laboratory assessments within 7 days prior to visit 1.
  • All subjects must weigh >= 15 kg at time of enrollment

Exclusion Criteria:

  • Subjects who have had any previous intestinal resection proximal to and including the ascending colon
  • Subjects with evidence of severe active Crohn's disease and/or, stricturing and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
  • Subjects who do not have a negative stool analysis, within the 30 days prior to visit 1
  • Subjects who have been screened/or enrolled in this study previously within the last 30 days
  • Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Entocort
Study Medication
Drug: Entocort
Entocort capsules, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: 12 weeks
Number of patients with at least one adverse event
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCDAI
Time Frame: Baseline to 8 weeks
Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
Baseline to 8 weeks
IMPACT 3
Time Frame: Baseline to 8 weeks
IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Padagis LLC

Investigators

  • Principal Investigator: Stanley Cohen, MD, Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA and Emory University School of Medicine, Atlanta, Georgia, USA
  • Study Director: Stefan Eklund, MD, AstraZeneca Pharmaceuticals, Mölndal, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9422C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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