Safety and Maintenance 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 as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453946
• Other study ID #: D9422C00002
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: February 2014

Study information

• Verified date: January 2022
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Safety for Maintenance of 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 as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2014
• Est. primary completion date: February 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.

• All subjects must weight >= 15 kg at the time of enrollment.

• Subjects must have been diagnosed and treated for 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 and have a PCDAI <= 10

Exclusion Criteria:

• Subjects who have had any previous intestinal resection proximal to and including the ascending colon.

• Subjects with evidence of active Crohn's disease (PCDAI > 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications.

• Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender (NOTE: Subjects from the induction protocol with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Entocort
Entocort capsules, taken orally, 6 mg daily.

Locations

Country	Name	City	State
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	London	Ontario
Germany	Research Site	München
Germany	Research Site	Nürnberg
Italy	Research Site	Firenze
Italy	Research Site	Messina
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	Buffalo	New York
United States	Research Site	Houston	Texas
United States	Research Site	Mays Landing	New Jersey
United States	Research Site	Newton	Massachusetts
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	Any kind of adverse event	16 weeks
Secondary	PCDAI	Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)	12 weeks
Secondary	IMPACT 3	IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE	12 weeks

External Links

•   CSR Synopsis