EUCTR2004-005018-35-DE进行中（未招募）不适用
Randomized, single-blind, multicentre study to compare the efficacy and safety of once daily 1 g mesalazine suppositories versus three times daily 0.5 g mesalazine suppositories in patients with acute ulcerative proctitis - OD vs. TID dosing with mesalazine suppositories in acute ulcerative proctitis
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
- 380
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
- •- signed informed consent
- •- Man or woman between 18 and 75 years of age
- •- Active ulcerative proctitis, i.e. inflammation/lesions maximal 15 cm of rectum
- •- Diagnosis confirmed by endoscopy and histological examination
- •- Established disease or new diagnosis
- •- Mildly to moderately active ulcerative proctitis (3 < DAI < 11)
- •- Women of child-bearing potential have to apply appropriate contraceptive methods
- •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
- •- Crohn’s disease
- •- proctitis of a different origin
- •- Prior bowel resection leading to diarrhoea and/or pouch formation
- •- Toxic megacolon
- •- Hemorrhagic diathesis
- •- symptomatic organic disease of the gastrointestinal tract
- •- Active colorectal cancer or a history of colorectal cancer
- •- Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years
- •- asthma, active peptic ulcer disease, infection
- •- Abnormal hepatic function or liver cirrhosis
- •- Abnormal renal function
- •- Regular oral treatment with more than 2 g/day 5-ASA, olsalazine or more than 5 g/day sulfasalazine within the last four weeks
- •- Regular rectal treatment with more than 0.5 g/day 5-ASA, olsalazine or more than 1 g/day sulfasalazine within the last four weeks
- •- Corticosteroid therapy within the previous one month
- •- Immunosuppressive drugs or anti-TNF-a therapy within the previous three months
- •- Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit
- •- Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile
- •-Intake of Cycloferon within the last four weeks
研究者
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