EUCTR2017-002258-36-ES进行中（未招募）1 期
A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •-Patients of both sexes aged between 18 and 75 years old, inclusively.
- •-Patients with diagnosis of CD, who had undergone curative ileocolonic resection, with ileocolonic anastomosis and for whom a randomization within 45 days from surgical intervention is feasible.
- •-If the patients had an end or loop ileostomy within 1 year prior to randomization, they can be included, but stoma closure should occur within 45 days prior to randomization.
- •-Patients have had faecal stream restoration at least 14 days prior to randomization.
- •-Patients must have at least one of the following risk factors for the development of early/severe post-operative endoscopic recurrence of their CD:
- •1) qualifying surgery that was their second intestinal resection within 10 years
- •2) third or more intestinal resections,
- •3) surgery for a penetrating CD complication (e.g., abscess or fistula), or
- •4) smoking 10 or more cigarettes per day for the past year.
- •-Patients treated with glucocorticosteroids (systemic or topical) must discontinue treatment within 6 weeks after surgery.
- •-Patients are capable of and willing to adhere to the study protocol requirements.
- •-Patients have provided signed and dated written informed consent.
- •-Female patients must be:
- •+post-menopausal (at least 2 years without spontaneous menses), or
- •+surgically sterile (bilateral tubal ligation, or hysterectomy, or ablation of both ovaries), or
- •+have a negative urine pregnancy test result at screening and at randomization and agree to use an acceptable method of contraception throughout their participation in the study. Acceptable methods of contraception include: condom and spermicide; intrauterine device (IUD), diaphragm with spermicide; hormonal methods (oral contraceptives, patches, implants, injectable or ring) with a documented failure rate of less than 1% per year,
- •+or commit to absolute and continuous sexual abstinence
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •?Presence of macroscopic evidence for CD proximally or distally to the site of resection (presence of frank erythema, oedema, aphthae, ulcers or wall thickening > 3 mm, or creeping fat) according to the surgeon or previous imaging
- •?Patients who had strictureplasties at index surgery
- •?Patients with an ileorectal anastomosis
- •?Patients with active perianal Crohn’s disease
- •?Patients treated with (treatment which was not discontinued at the time of surgery):
- •?Aminosalicylates
- •?Any biologicals (e.g., TNF-a inhibitor, natalizumab, or
- •similar drugs)
- •?Azathioprine, 6-mercaptopurine
- •?Methotrexate,
- •?Cyclosporine, tacrolimus, sirolimus, mycophenolate
- •mofetil, or similar drugs
- •?antibiotics specific for CD such as metronidazole or
- •ciprofloxacin
- •?Patients with active infectious, ischemic, or immunological diseases with GI involvement
- •?Patients with symptoms attributed to Short Bowel Syndrome (more than cm 100 in total of small bowel resected);
- •?Patients with sepsis or other post-operative complications necessitating use of antibiotics for more than 14 days after surgery.
- •?Patients with colorectal stenosis precluding ileocolonoscopy.
- •?Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation
- •?Hepatic Impairment defined as severe (Child-Pugh C) hepatic impairment or patients with MELD (Model for End-Stage Liver Disease) score > 25.
- •?Patients with an alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 upper limit of normal (ULN) at randomization.
- •?Patients with severe cardiac insufficiency (NYHA, New York Heart Association classes 3 – 4).
- •?Patient has a history of sensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of Rifaximin -EIR
- •?Patients with kidney failure at randomization.
- •?Any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including HIV infection), haematological, or neoplastic disease.
- •?Pregnant or nursing woman
- •?Patients who have donated 250 ml or more of blood in the last 3 months.
- •?Patients who have used any investigational drug (except biological therapies) within 3 months prior to screening.
研究者
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