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NCT01444092 Clinical Trial

Safety Study of Entocort for Children With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01444092
Other study ID # D9422C00001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2011
Est. completion date September 2014

Study information
Verified date January 2022
Source Padagis LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Entocort
Entocort capsules, oral

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

Sponsors (1)
Lead Sponsor Collaborator
Padagis LLC

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event Number of patients with at least one adverse event 12 weeks
Secondary PCDAI Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst). Baseline to 8 weeks
Secondary IMPACT 3 IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best). Baseline to 8 weeks
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Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
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Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
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