A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease
- Conditions
- Treatment of moderate, active Crohn’s disease: induction of remission.MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
- Registration Number
- EUCTR2007-001014-17-FR
- Lead Sponsor
- Alfa Wassermann S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 424
• patients of either sex;
• patients aged between 18 and 75 years old, inclusively;
• diagnosis of Crohn's disease localised in the ileum and/or colon, documented either radiologically or endoscopically at least 3 months previously;
• patients with a CDAI of = 220 to = 400;
• patients capable of and willing to conform to the study protocol;
• patients who have provided signed and dated written informed consent;
• if the patient is female, she must be:
- postmenopausal (at least 2 years without spontaneous menses), or
- surgically sterile (tubal ligation, or hysterectomy, or ablation of both ovaries), or
- she must have a negative urine pregnancy test result at screening and at enrolment and agree to use an acceptable method of contraception. Acceptable methods of contraception include: condom and spermicide; intrauterine device (IUD), diaphragm, preferably with spermicide; hormonal methods (oral contraceptives, patches, implants, injectable or ring).
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
• patients potentially needing immediate surgery for Crohn's disease, including patients with occlusive symptoms and/or stenotic tract with dilation above;
• patients with active perianal Crohn’s disease;
• patients with other infectious, ischemic, or immunological diseases with gastrointestinal involvement;
• patients with symptoms attributed to Short Bowel Syndrome or previous surgery;
• patients with stoma;
• patients affected by upper gastro-intestinal disease (gastro-duodenum-jejunum Crohn’s disease) alone or in combination with colitis or ileitis;
• patients treated with:
- oral steroids and budesonide less than 30 days prior to screening;
- i.v. steroids less than 30 days prior to screening;
- antibiotics (such as metronidazole, tinidazole, ciprofloxacin, clarithromycin) less than 15 days prior to screening;
- rectal steroids less than 30 days prior to the screening visit;
- anti-tumour necrosis factor (anti-TNF) and other biological therapies less than 6 months prior to the screening visit;
• pregnant women or nursing mothers;
• females of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrolment;
• patients with severe hepatic insufficiency (Child C);
• patients with severe cardiac insufficiency (NYHA - New York Heart Association classes 3 – 4);
• patients with known hypersensitivity to Rifaximin;
• 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;
• withdrawal of informed consent;
• patients who have used any investigational drug (except biological therapies) within 3 months prior to screening;
• patients who have donated 250 ml or more of blood in the last 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Dose range finding study to evaluate the efficacy (induction of remission) and safety of 3 doses of Rifaximin-EIR 400 mg tablet versus placebo in the treatment of active, moderate Crohn’s disease.;Secondary Objective: N/A;Primary end point(s): Clinical remission (defined as reduction in CDAI score < 150 points) at 12 weeks. <br><br>Secondary end points:<br>• clinical response defined as a reduction in CDAI of = 100 points from baseline value;<br>• clinical response defined as a reduction in CDAI of = 70 points from baseline value;<br>• time to obtain clinical response and remission;<br>• maintenance of clinical remission at second week after stopping therapy;<br>• maintenance of clinical remission, i.e. CDAI score < 150 points at the end of follow-up; (12 weeks after stopping therapy);<br>• number of treatment failures;<br>• definition of therapeutic dose to be used in subsequent phase III clinical trials.<br>
- Secondary Outcome Measures
Name Time Method