Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• Ulcerative colitis diagnosis by Lennard-Jones criteria

• ≥18 years

• Left or extended extent of disease

• Moderate flares of ulcerative colitis according to disease activity index (DAI)

• No maintenance therapy or 5ASA treatment

• The patient is available to understand study procedures and to sign the inform consent form

• Inform Consent Form

Exclusion Criteria:

• Previous or current thiopurines, methotrexate or biological treatment

• Administration of systemic corticoids the last 6 months

• Acute or moderate systemic infection

• Diabetes mellitus or arterial hypertension

• Pregnancy or breastfeeding

• Allergic reactions associated to corticosteroids therapy