Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-007329-38-IT
• Date of registration: 21/01/2009
• Prospective Registration: Yes
• Primary sponsor: ERYDEL S.P.A.
• Public title: Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease
• Scientific title: Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease
• Date of first enrolment: 06/02/2009
• Target sample size: 184
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007329-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. male and female patients; 2. age > 18 years, 3. patients with steroid-dependent Crohn?s disease, including patients with intolerance or resistance to AZT/6-MP/MTX, in clinical remission (CDAI < 150) for at least 4 weeks after a fixed schedule of methylprednisolone tapering; 4. patients willing and able to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1)patients with Crohn?s disease with intestinal sub-occlusion, or suspect of abdominal abscess, or with active perianal disease, or with clinically active disease at randomization (CDAI > 150); 2) patients already on therapy with immunosuppressant agents (AZT, 6-MP, MTX) for less than 6 months; 3) patients having received therapy with infliximab in the previous 3 months; 4)investigational treatments in the previous 3 months since the randomization; 5) pregnant women, or women who are not using valid birth-control measures, except those in surgical menopause; breast feeding women; 6) non collaborating subjects or unable to be compliant with the treatment and the study schedules 7) severe concomitant diseases such as : (a)patients with inadequate ?bone marrow reserve?: WBC < 3000 /mm3; PLTs < 75000 /mm3; Hb < 10 gr/dl; (b) liver disease with total bilirubin >= 3 times the upper limit of normal (ULN), AST (GOT) >= 5 ULN, alkaline phosphatase >= 5 ULN; (c) renal disease with serum creatinine >= 3 mg/dl; (d) serious cardiac, allergic, lung, neurological diseases, neoplastic or pre-neoplastic disease; (e) diseases (other than Crohn?s) requiring chronic steroid treatment; 8)Elective surgery already scheduled at the start of the study; 9)Chronic use of alcohol, drug addiction; 10) Subjects with contra-indication to the use of steroids (i.e. systemic fungal infections).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with steroid-dependent Crohn?s Disease
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Intervention(s)

Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: dexamethasone sodium phosphate
CAS Number: 2392-39-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Route of administration not applicable

Primary Outcome(s)

Main Objective: Assessment of the efficacy of ERY-DEX vs placebo in maintaining patients with steroid-dependent Crohn?s disease in clinical remission throughout 12 months without oral steroids.

Primary end point(s): Proportion of patients maintaining steroid-free clinical remission (CDAI < 150) without surgery throughout 12 months.

Secondary Objective: 1.safety of ERY-DEX; 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. indirect costs of care.

Secondary ID(s)

CRODEX01