EUCTR2004-001109-81-CZ进行中（未招募）1 期
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
Chiesi Farmaceutici SpA0 个研究点目标入组 320 人开始时间: 2004年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? 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
排除标准
- •? 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
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