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

September 18, 2012 updated by: Erydel

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant'Orsola
      • Firenze, Italy, 50100
        • Ospedale Careggi
      • Forlì, Italy, 57100
        • Ospedale Morgagni Pierantoni
      • Padova, Italy, 35128
        • Policlinico Universitario
      • Palermo, Italy, 90100
        • Ospedale Cervello
      • Rome, Italy, 00133
        • Policlinico Tor Vergata
      • Rome, Italy, 00152
        • Ospedale San Camillo
      • Rome, Italy, 00100
        • Complesso Integrato Columbus
      • San Donato Milanese, Italy, 20097
        • A.O. San Donato
  • Romania
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Județean de Urgență
  • Spain
      • Barcelona, Spain, 08036
        • Clinic CIBER EHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ery-dex
Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval
Drug: Dexamethasone
500 mg/20 ml encapsulated in erythrocytes, every month for 12 months
Other Names:
  • Ery-dex
Placebo Comparator: Placebo
placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval.
Drug: Dexamethasone
500 mg/20 ml encapsulated in erythrocytes, every month for 12 months
Other Names:
  • Ery-dex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients maintaining steroids-free clinical remission (CDAI<150) without surgery for 12 months
Time Frame: after 12 months
after 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of safety by comparison of treatment emergent AE
Time Frame: after 12 months
after 12 months
proportion of patients interrupting the study because of adverse events
Time Frame: after 12 months
after 12 months
duration of the period of clinical remission
Time Frame: after 18 months
after 18 months
dosing of serum cortisol
Time Frame: after 12 months
basal and following ACTH trigger
after 12 months
evaluation of inflammation indexes (ESR, CRP)
Time Frame: after 12 months
after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erydel

Investigators

  • Principal Investigator: Angelo Andriulli, MD, Unafilliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 13, 2011

First Posted (Estimate)

January 14, 2011

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Crodex01
  • 2008-007329-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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