A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease

Phase 1

• Conditions: Crohn's disease; MedDRA version: 12. Level: LLT Classification code 10013099 Term: Disease Crohns

• Registration Number: EUCTR2010-022017-26-GB
• Lead Sponsor: Central Manchester University Hospitals Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-08
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

1) patients aged 8 to 17 years
2) diagnosis of Crohn’s disease by established clinical, endoscopic, histological and radiological criteria
3) clinically active disease defined as a paediatric Crohn’s disease activity index (PCDAI) score of >15
4) clinical decision made to commence oral prednisolone
5) parental and child consent to participate in the study.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) severe CD requiring intravenous corticosteroids or likely to require surgery,
2) having received systemic corticosteroids during the preceding 6 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified