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

Phase 4CompletedNCT01941589

Sheba Medical Center149 enrolled

Overview

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.

he 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

149

Conditions

Ulcerative Colitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Ulcerative Colitis exacerbation as defined by a Lichtiger score of \>10 * age \>18 * if taking thiopurines, the dose must be stable for 2 months prior to admission Exclusion Criteria: * pregnant women * allergy/unable to take study medications * active infection * severe renal/liver/cardiorespiratory condition * toxic megacolon or signs of imminent colectomy * treatment with an anti-tumor necrosis factor in 3 months prior to admission * prior treatment with cyclosporin or tacrolimus * alcohol dependancy * unwilling/ unable to give an informed consent * participation in clinical trials in the last 2 months prior to admission

Locations (10)

6th affiliated hospital of Sun yat-sen university

Guangzhou, China

Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, France

Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

Heraklion, Greece

Department of Gastroenterology, University Hospital & Medical School of Ionnina

Ioannina, Greece

Gastroenterology department, Soroka medical center

Beersheba, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Università di Roma Sapienza

Rome, Italy

Zvezdara University Clinical Center, Gastroenterology Department

Belgrade, Serbia

nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

percentage of patients who respond to the treatment

Time frame: day 7

Secondary Outcomes

the percentage of patients in need of a rescue medication

Time frame: day 5, 7

colectomy rate

Time frame: 1 month, 3 months post randomization