Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Interventions
Product Name: Rifaximin-EIR
Pharmaceutical Form: Gastro-resistant tablet
CAS Number: 80621-81-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical
Sponsors
Alfa Wassermann S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Secondary end points: • clinical response defined as a reduction in CDAI of = 100 points from baseline value; • clinical response defined as a reduction in CDAI of = 70 points from baseline value; • time to obtain clinical response and remission; • maintenance of clinical remission at second week after stopping therapy; • maintenance of clinical remission, i.e. CDAI score < 150 points at the end of follow-up; (12 weeks after stopping therapy); • number of treatment failures; • definition of therapeutic dose to be used in subsequent phase III clinical trials. | — |
Countries
France, Germany, Hungary, Italy
Outcome results
None listed