Trial | NCT01277289  Report issue

Title

Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    urea ...

  • Study Participants

    51
The aim of this study is the assessment of the efficacy of Ery-Dex (dexamethasone intra-erythrocyte) versus placebo in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids.
The medical treatment of Crohn's disease is still unsatisfactory despite the use of large number of drugs as steroids which cause several side effects after a long-term treatment.Ery-Dex thanks its peculiar way of administration (intra-erythrocyte encapsulation and release at very low doses during 1 month)should dramatically reduce side effects due steroids, which are dose dependent, and provide an alternative for long-term glucocorticoid therapy.
Study Started
Apr 30
2009
Primary Completion
Dec 31
2011
Study Completion
Jun 30
2012
Last Update
Sep 19
2012
Estimate

Drug Dexamethasone

500 mg/20 ml encapsulated in erythrocytes, every month for 12 months

  • Other names: Ery-dex

Ery-dex Experimental

Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval

Placebo Placebo Comparator

placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval.

Criteria 

Inclusion Criteria:

male and female patients;
age > 18 years
patients with steroid-dependent CD in clinical remission showing a relapse in the last 12 months and in treatment with 10mg of methylprednisone at least
patients willing and able to give written informed consent

Exclusion Criteria:

CD with intestinal sub-occlusion, or suspected abdominal abcess, or active perianal disease or CDAI >150
pts. already on therapy with immunosuppressant agents for less than 4 months
pts. receiving Infliximab (or other anti-TNF) in the previous 3 months
severe concomitant diseases
elective surgery already scheduled at the start of the study
chronic use of alcohol; drug addiction
pregnant women
subjects with contra-indication to the use of steroids
investigational treatments in the previous 3 months
No Results Posted