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Clinical Trials/EUCTR2016-001170-15-ES
EUCTR2016-001170-15-ES
Active, not recruiting
Phase 1

Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM

GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)0 sites148 target enrollmentAugust 2, 2017

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Moderate flares of Ulcerative Colitis
Sponsor
GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)
Enrollment
148
Status
Active, not recruiting
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 2, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)

Eligibility 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
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes

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

Outcomes

Primary Outcomes

Not specified

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