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Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis

NCT02921555 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-02-21

Study results available
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Summary

The purpose of this study is to determine the efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.

Conditions

Interventions

DRUG

Methylprednisolone

Intravenous bolus of methylprednisolone 0.5g/day for 3 consecutive days followed by a decreasing conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)

DRUG

Prednisone

Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)

Sponsors & Collaborators

  • Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

    lead OTHER

Principal Investigators

  • Eugeni Domènech, MD, PhD · Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2022-11-07
Completion
2022-11-07

Countries

  • Spain

Study Locations

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Entities

Drugs
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 NCT02921555 on ClinicalTrials.gov