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

Phase 4

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: corticosteroids only; Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

• Registration Number: NCT01941589
• Lead Sponsor: Sheba Medical Center

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-08-30
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-ASA naive arm 2	corticosteroids only	IV corticosteroids only / PO Methylprednisolone
present 5-ASA arm 2	corticosteroids only	IV corticosteroids only / PO Methylprednisolone
present 5-ASA arm 1	oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone	oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
5-ASA naive arm 1	oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone	oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

Primary Outcome Measures

Name	Time	Method
percentage of patients who respond to the treatment	day 7

Secondary Outcome Measures

Name	Time	Method
colectomy rate	1 month, 3 months post randomization
the percentage of patients in need of a rescue medication	day 5, 7

Trial Locations

Locations (10)

Zvezdara University Clinical Center, Gastroenterology Department; 🇷🇸 Belgrade, Serbia

Department of Gastroenterology, University Hospital & Medical School of Ionnina; 🇬🇷 Ioánnina, Greece

Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, China

Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou; 🇬🇷 Heraklion, Greece

Università di Roma Sapienza; 🇮🇹 Rome, Italy

Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne; 🇫🇷 Saint-Etienne, France

Gastroenterology department, Soroka medical center; 🇮🇱 Be'er Sheva', Israel

6th affiliated hospital of Sun yat-sen university; 🇨🇳 Guangzhou, China

Sheba Medical Center; 🇮🇱 Tel HaShomer, Israel

nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of