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

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Dexamethasone Erythromycin Erythromycin stearate Dexamethasone acetate Erythromycin ethylsuccinate Dexamethasone sodium phosphate Erythromycin phosphate

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

evaluation of safety by comparison of treatment emergent AE [ Time Frame: after 12 months ] [ Designated as safety issue: Yes ]
proportion of patients interrupting the study because of adverse events [ Time Frame: after 12 months ] [ Designated as safety issue: Yes ]
duration of the period of clinical remission [ Time Frame: after 18 months ] [ Designated as safety issue: No ]
dosing of serum cortisol [ Time Frame: after 12 months ] [ Designated as safety issue: Yes ]
basal and following ACTH trigger
evaluation of inflammation indexes (ESR, CRP) [ Time Frame: after 12 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Ospedale San Camillo
Rome, Italy, 00152
Policlinico Tor Vergata
Rome, Italy, 00133
Complesso Integrato Columbus
Rome, Italy, 00100
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

No publications provided

Responsible Party:	Erydel
ClinicalTrials.gov Identifier:	NCT01277289 History of Changes
Other Study ID Numbers:	Crodex01, 2008-007329-38
Study First Received:	January 5, 2011
Last Updated:	September 18, 2012
Health Authority:	Italy: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions
Antiemetics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013

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