Efficacy of mesalazine to prevent relapse in paediatric crohn?s disease

Completed

• Conditions: Paediatric crohn's disease; Digestive System; Crohn's disease

• Registration Number: ISRCTN84003996
• Lead Sponsor: Ferring SA (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Children less than 18 years old, either sex
2. Diagnosed with crohn?s disease before the age of 16 by means of clinical, radiological, endoscopic and histological data
3. Had to be in an active phase defined by:
3.1. A Harvey Bradshaw score (HB) greater than or equal to 5, and
3.2. An erythrocyte sedimentation rate (ESR) greater than or equal to 25 mm at hour one
4. All lesion localisations, except exclusive anorectal localisation, were included, providing patients? lesion extension had been assessed within two years prior to inclusion

After flare-up treatment, inclusion criteria were as follows:
1. Patients in clinical remission within six months following flare-up treatment initiation at pre-inclusion
2. An HB score under 5
3. An ESR under 25 mm
4. Normal hepatic and renal functions

Exclusion Criteria

1. Flare-up had been treated with mesalazine or had required immuno-suppressors
2. Patients with known hypersensitivity to salicylate
3. Patients whose flare-up had occurred at pre-inclusion when on a 5-aminosalicylic acid (5-ASA) dose greater than 50 mg/kg/day for over two months

Study & Design

• Study Type: Interventional
• Study Design: Not specified