drugset / Trial / NCT01941589

Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis

NCT01941589

Phase 4 Completed 149 enrolled Sheba Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

Timeline

Start
2013-09
Primary completion
2021-04
Completion
2021-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mesalamine Small molecule 4 g Oral
Comparator Hydrocortisone Other / unclassified Intravenous
Comparator Methylprednisolone Other / unclassified Oral

Indications