Active Crohn's ileitis MedDRA version: 6 Level: high Classification code 10011401
Conditions
Interventions
Trade Name: Clipper
Product Name: Clipper
Product Code: CHF 1514
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Sponsors
Chiesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Czech Republic
Outcome results
None listed