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
ConditionsModerate flares of Ulcerative ColitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsUrbason
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.
Investigators
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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