EUCTR2006-004230-32-PL进行中（未招募）1 期
EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study
Chiesi Farmaceutici SpA0 个研究点目标入组 300 人开始时间: 2007年9月5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
- 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 and = 70 years old;
- •- women of child-bearing potential using effective contraceptive methods;
- •- 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) For patients under treatment with other oral medication containing 5 ASA maximum allowed dosage at study entry is: balsalazide (6.7 g/day), or olsalazine (2 g/day) or sulfasalazine (3 g/day) in the last 14 days;
- •- Able to understand and to follow the protocol;
- •- Having given written informed consent for study participation;
- •Inclusion criteria at randomization (end of run-in period)
- •- Endoscopic score = 1 in one or more colon segments;
- •- DAI score = 3 and < 10;
- •- Confirmation of rectal bleeding score = 1;
- •- Negative stool examination for infectious disease;
- •- Absence of concomitant medications since the screening visit (especially for non authorized treatments);
- •- 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 of childbearing potential not using adequate contraceptive methods;
- •- Pregnant women or breast-feeding women;
- •- Severe ulcerative colitis or toxic megacolon;
- •- Infectious Colitis;
- •- Ischemic Colitis;
- •- Colitis induced by drug or radiotherapy;
- •- Chron'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)
- •- Hyperthyroidism;
- •- Medical history of concomitant cancer or other disease which, according to Investgators' opinion could interfere with the evaluation of the test drug;
- •- Poorly controlled pulmonary infections (tubercolosis, active mycotic infections);
- •- Patients receiving oral or injectable corticosteroids (oral budesonide included) within 30 days from screening visit, rectal corticosteroids (suppositories, enema, foams), inhaled corticosteroids in the 14 days prior to screening visit;
- •- Change in the dose of oral Mesalazine treatment, in the 14 days prior the screening visit or at a dosage superior to 3.2 g/day or balsalazide (6.7 g/day), olsalazine (2 g/day), or sulfasalazine (3 g/day);
- •- Patients being treated with H2-receptor antagonists or proton pump inhibitor (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 cannot be stopped before randomization;
- •- History of drug or alcohol abuse;
- •- Patients who took part to another trial in the previous 3 months-
- •Exclusion criteria at randomization (end of run-in period)
- •- Severe ulcerative colitis (DAI > 10);
- •- Positive ova and parasitic stool examination;
- •- Ulcerative Colitis with endoscopic store < 1 or rectal bleeding score < 1;
- •- Ulcerative Colitis limited to the rectum;
- •- Chron's Disease;
- •- Significant hepatic impairment (AST or ALT twice the upper limit of normal range);
- •- Significant renal impairment (sreum creatinine > 1.5 mg/dL);
- •- Any abnormal laboratory test which could interfere with the protocol
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