A randomised, controlled with placebo, double blind, double dummy, parallel group study on the therapeutic efficacy and safety of Beclomethasone dipropionate (BDP) in the treatment of patients with post-active Crohn’s Ileitis with remission induced by a course of systemic steroid - N/A

Phase 1

• Conditions: Active Crohn's ileitis; MedDRA version: 6Level: highClassification code 10011401

• Registration Number: EUCTR2004-001109-81-CZ
• Lead Sponsor: Chiesi Farmaceutici SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-03
• Study Completion: 2007-02-12
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

? Written informed consent;
? male or female of at least 18 year old;
? clinical diagnosis of active Crohn’s disease defined by a Crohn’s Disease Activity Index (CDAI) between 180 and 400;
? Active Crohn’s disease confined mainly to the distal ileum, ileocecal region, and/or ascending colon as verified by colonscopy or x-rays during at least 24 months before randomisation.
? Study medication compliance ? 80 % during the run-in period

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

? Patients with any major manifestation of Active Crohn’s disease in the colon (except rare aphtae), rectum, and perianal Crohn disease
? Patients with septic complications, abscesses, perforation or active fistulae
? Patients that have had ileostomy, resection of the ileum more then 100 cm, or who required immediate surgery
? Patients treated with antitumor necrosis factor in the 6 months before the start of the study
? Patients receiving steroids and other immunosuppressive drugs.
? Positive stools culture for enteric pathogenic ova or parasites or clostridium difficile toxin;
? Less than 80% compliance during run-in period;
? Treatment with total parenteral nutrition (TPN) and with total enteral nutrition (TEN) will be stopped within 3 weeks prior to screening;
? Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological endocrine, pulmonary, cardiac, neurological or cerebral disease;
? Clinically significant or unstable concurrent disease: uncontrolled diabetes, uncontrolled hyperthyroidism, significant renal impairment (serum creatinine > 1,5 mg/dl), significant hepatic impairment (AST or ALT twice the upper limit of the normal range), poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastro-intestinal (i.e. active peptic ulcer), neurological or haematological, autoimmune diseases
? Cancer or any chronic disease with prognosis < 2 years
? Pregnant and breast feeding women
? History of alcohol or drug abuse
? Allergy, sensitivity or intolerance to study drugs and/or study drugs formulations ingredients
? Patients that have received investigational new drugs within the last 12 weeks
? Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
? Patients who have been previously enrolled in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary end-point of the study is to compare the therapeutic efficacy of the two treatments by assessment of the following parameter: relapse rate, defined as a Crohn’s Disease Activity Index (CDAI) > 150 (6), with at least of 60 points over the value registered at randomisation. Time to relapse is the secondary efficacy criterion.<br><br>;Main Objective: To evaluate efficacy of BDP 15 mg die (for 2 weeks) and 10 mg die (for 22 weeks), in comparison with placebo, in patients with Crohn’s Disease in maintaining the remission induced by a course of systemic steroids verifying the relapse rate.;Secondary Objective: To compare the tolerability of the two treatments by means of laboratory test, and evaluating the occurrence of Adverse Events.