Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

Summary

Primary objective: Assessment of the efficacy of EryDex vs PLACEBO in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids. Secondary objectives: 1. safety of EryDex 2. emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients; 3. duration of the period of remission; 4. evaluation of the hypophysis-adrenal function; 5. study of plasma concentrations of dexamethasone; 6. effect of therapy on the metabolism of calcium and on indexes of inflammation; 7. assessing the quality of life; 8. rate of surgical resection 9. evaluation of the indirect costs of care.

Timeline

Start

2009-06-03

Primary completion

2011-12-30

Completion

2012-06

Outcome

Outcome not reported

Stopped (Enrollment): “due to the difficulty to enroll suitable patients”

Drugs

Indications