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

This study has been terminated.
(due to the big difficulty to enrol suitable patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277289
First Posted: January 14, 2011
Last Update Posted: September 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erydel
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Drug: Dexamethasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Erydel:

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

Secondary Outcome Measures:
  • evaluation of safety by comparison of treatment emergent AE [ Time Frame: after 12 months ]
  • proportion of patients interrupting the study because of adverse events [ Time Frame: after 12 months ]
  • duration of the period of clinical remission [ Time Frame: after 18 months ]
  • dosing of serum cortisol [ Time Frame: after 12 months ]
    basal and following ACTH trigger

  • evaluation of inflammation indexes (ESR, CRP) [ Time Frame: after 12 months ]

Enrollment: 51
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Ery-dex

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277289


Locations
Italy
Policlinico Sant'Orsola
Bologna, Italy, 40138
Ospedale Careggi
Firenze, Italy, 50100
Ospedale Morgagni Pierantoni
Forlì, Italy, 57100
Policlinico Universitario
Padova, Italy, 35128
Ospedale Cervello
Palermo, Italy, 90100
Complesso Integrato Columbus
Rome, Italy, 00100
Policlinico Tor Vergata
Rome, Italy, 00133
Ospedale San Camillo
Rome, Italy, 00152
A.O. San Donato
San Donato Milanese, Italy, 20097
Romania
Spitalul Clinic Judetean De Urgenta
Cluj-Napoca, Romania, 400006
Spain
Clinic CIBER EHD
Barcelona, Spain, 08036
Sponsors and Collaborators
Erydel
Investigators
Principal Investigator: Angelo Andriulli, MD Unafilliated
  More Information

Responsible Party: Erydel
ClinicalTrials.gov Identifier: NCT01277289     History of Changes
Other Study ID Numbers: Crodex01
2008-007329-38 ( EudraCT Number )
First Submitted: January 5, 2011
First Posted: January 14, 2011
Last Update Posted: September 19, 2012
Last Verified: September 2012

Keywords provided by Erydel:
dexamethasone
ery-dex
Chron's disease
CD

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action