Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).

• Status: Completed
• Trial end date: 2021-05-11
• Target enrollment: 0
• Participant gender: All

Summary

The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation.

The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Treatments: Aminosalicylic Acid; Mesalamine

Criteria

Inclusion Criteria:

• UC known and diagnosed by established clinical-endoscopic and histological criteria or newly-diagnosed UC, based on clinical and endoscopic findings, and about to start treatment with corticosteroids.

• Current hospitalization with Severe UC exacerbation as defined by a Lichtiger score of >10

• Age >18

• Has not been on oral systemic corticosteroids more than 14 days prior to hospitalization

• If taking a thiopurine, the dose need to be stable for the last 2 months before admission

Exclusion Criteria:

• Pregnant women

• Allergy / unable to take prednisone / hydrocortisone/ 5-ASA.

• Active infection - either enteric or elsewhere

• Severe renal, liver or cardio respiratory comorbidity

• Toxic megacolon, or clinical features suggestive of a need for imminent colectomy

• Treatment with an anti-TNF within the prior 3 months

• Prior treatment with cyclosporine or tacrolimus within the prior 3 months

• Alcohol dependency

• Unable or unwilling to provide informed consent

• Participating in other clinical trial within the 2 months prior to admission