Mesalalazine in pediatric ulcerative colitis

Phase 1

• Conditions: lcerative colitis; MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-004851-35-FI
• Lead Sponsor: Children´s Hospital, University of Helsinki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Mild or moderate clinical disease activity according to the validated activity index PUCAI
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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

Crohn´s disease
Corticosteroid therapy
Dose adjusting in immunosuppressants within 90 days

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare once daily dosing to twice daily dosing;Secondary Objective: extension study to study the effect of 3 week therapy with rectal enemas;Primary end point(s): 6 weeks or clinical indication for enhancement of therapy;Timepoint(s) of evaluation of this end point: 0,2,3 and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Disease activation needing therapy enhancement within 6 weeks;Timepoint(s) of evaluation of this end point: Any time within 6 weeks