EUCTR2008-000045-59-FR进行中（未招募）1 期
Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ferring SAS
- 入组人数
- 398
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
- •Aged over 18 years.
- •Newly diagnosed or relapsing mild to moderate ulcerative colitis with disease extension beyond rectum (of at least 12-18 cm from the anorectal junction). All patients must have had at least one total colonoscopy in their disease history (within the previous 5 years).
- •Disease activity will be assessed on the 7 days before inclusion and according to ulcerative colitis disease activity index (UC-DAI) score. The UC-DAI score will be from 3 to 8 (mild: 3-5 or moderate: 6-8).
- •Men or non pregnant women.
- •Women with childbearing potential must be using a contraceptive method judged effective by the investigator.
- •Oral maintenance treatment with azathioprine or 6-mercaptopurine (taken for at least 6 months and continued at the same dose throughout the study) is permitted.
- •Informed consent given.
- •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
- •Proctitis (less than12-18 cm from the anorectal junction).
- •Previous colonic surgery.
- •Previous failed to respond to steroids within the previous year.
- •Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose > 3/day for induction of remission within the previous year.
- •Current relapse lasting more than 6 weeks (from what patient says).
- •Severe/fulminant ulcerative colitis.
- •Evidence of other forms of inflammatory bowel disease or infectious disease.
- •Allergy to aspirin or salicylate derivatives.
- •The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary):
- •- Loperamide and other antidiarrheal agents, mucilages, antibiotics (metronidazole
- •and ciprofloxacin): 1 week wash-out.
- •- Oral steroids: 4 weeks wash-out.
- •- Rectal steroids: 2 weeks wash-out
- •- Repeated treatment (> 3days of use) of non steroidal anti-inflammatory drugs
- •(NSAID) oral or rectal route: 1 week wash-out (aspirin =325 mg/day used for
- •cardioprotection is allowed).
- •- Sulfasalazine > 4g or mesalazine or 4-ASA at a higher dose than what it is
- •permitted in the local formulary or standard care for maintenance treatment: 4
- •weeks wash-out.
- •- Immunomodulating/suppressing drugs: 3 month for wash out (except for
- •patients maintained on azathioprine or 6-mercaptopurine -see above).
- •Known significant hepatic or renal function abnormalities.
- •Moderate/severe abnormal renal, hepatic or blood count tests defined as: creatinine plasma value > 1.5 x ULN or white blood cells < 3500/mm3 or > 15000/mm3 or platelets < 100000/mm3 or > 800000/mm3 or ASAT/ALAT > 3 x ULN or GGT/Alkalin Phosphatases > 3x ULN (Primary Sclerosing Cholangitis is not an exclusion criteria),
- •History or physical examination findings indicative of active alcohol or drug abuse,
- •Pregnancy or breast-feeding,
- •History of disease, including mental/emotional disorder, that might interfere with their participation in the study,
- •Participation in another clinical study in the last 3 months.
- •Inability to comply with the protocol requirements.
- •Inability to fill in the diary cards.
研究者
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