EUCTR2006-004230-32-BE进行中（未招募）不适用
Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Pre-inclusion criteria at screening visit : •Male or female >18 or <70 years old; •Women with childbearing potential using efficient contraceptive method •History and documented diagnosis of ulcerative colitis, dated from more than 3 months •Rectal bleeding score =1 •Stable dosage of ongoing oral mesalazine therapy (maximum dosage 3.2 g/day) or balsalazide (6.7 g/day), or olsalazine (2 g/day) or sulfasalazine (3 g/die) in the last 14 days •Able to understand and to follow the protocol •Having given written informed consent for study participation Inclusion criteria at randomisation (end of run-in period) •Endoscopic score = 1 in one or more colon segments •DAI score =3 and <10 •Confirmation of a rectal bleeding score = 1 •Negative stool examination for infectious disease •Absence of modification of concomitant medications since the screening visit (specially for non authorised treatment) ?Negative pregnancy test for women.
- •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
- •Exclusion criteria at screening : •Women with childbearing potential and without efficient contraceptive method •Pregnant or breast-feeding women •Severe ulcerative colitis or toxic megacolon •Infectious colitis •Ischemic colitis •Colitis induced by drug or radiotherapy •Crohn’s disease •Major gastro-intestinal surgery other than appendectomy •Evolutive active peptic ulcer or medical history of peptic ulcer complications •Non compensated diabetes mellitus •Non controlled arterial hypertension (SBP =160 mm Hg and/or DBP= 100 mm Hg) •Hypertyroidism •Medical history of cancer or other concomitant diseases that, according to Investigator’s opinion, could interfere with the evaluation of the test drugs •Poorly controlled pulmonary infections (tubercolosis,active mycotic infections) ?Patients receiving oral or injectable corticosteroids (oral Budesonide included)within 30 days from screening visit, rectal corticosteroid(suppositories,enemas,foams),inhaled corticosteroids ,within 14 days from screening visit ?Change in the oral dose of mesalazine treatment within 14 days from screening visit or at a dosage superior to 3 g/day or balsalazide (6.7 g/day), or olsalazine (2 g/day) or sulfasalazine (3 g/die). ?Patients being treated with H2- receptor antagonists or proton pump inhibitors (PPIs) in the previous 2 weeks •Use of immunomodulators or immunodepressants in the previous 3 months •Patients treated with TNF-alfa antagonists in the previous 6 months •Antibiotic treatment that can not be stopped before randomisation •History of drugs or alcohol abuse •Patients who took part to another clinical study in the previous 3 months Exclusion criteria at randomisation (end of run-in period) •Severe ulcerative colitis (DAI > 10). •Positive ova or parasitic stool examination •Ulcerative colitis with endoscopic score < 1 or rectal bleeding score <1 •Ulcerative colitis limited to the rectum •Crohn’disease •Significant hepatic impairment (ALT or AST twice the upper limit of normal range) •Significant renal impaiment (serum creatinine >1.5 mg/dL) •Any abnormal laboratory test which could interfere with the protocol.
研究者
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Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study.Mild to moderate Ulcerative colitisOral and Gastrointestinal - Inflammatory bowel diseaseACTRN12609001010280Chiesi Farmaceutici S.p.A.244
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