drugset / Trial / NCT01941589
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mesalamine | Small molecule | 4 g | Oral |
| Comparator | Hydrocortisone | Other / unclassified | — | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | — | Oral |