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

NCT01941589 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2022-05-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids

DRUG

corticosteroids only

IV corticosteroids only

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ofir Har-Noy, MD · Sheba Medical Center, Tel-Hashomer, ISRAEL 52621

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • China
  • France
  • Greece
  • Israel
  • Italy
  • Serbia
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01941589 on ClinicalTrials.gov