Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.

• Register: EUCTR
• Last refreshed on: 25 March 2013
• Main ID: EUCTR2011-002821-24-IT
• Date of registration: 27/02/2012
• Prospective Registration: No
• Primary sponsor: ALFA WASSERMANN
• Public title: Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.
• Scientific title: Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. - RETIC-PD/006/2011
• Date of first enrolment: 21/07/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002821-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Italy

Contacts

• Name: Direzione Ricerca Clinica
• Affiliation: Alfa Wassermann SpA

• Name: Direzione Ricerca Clinica
• Affiliation: Alfa Wassermann SpA

Key inclusion & exclusion criteria

Inclusion criteria:
The study will include patients with active, moderate Crohn’s disease defined by a CDAI score of = 220 and = 400, localised in the ileocolon or colon (documented either radiologically or endoscopically at least 3 months before inclusion in the study).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
Patients with symptoms attributed to Short Bowel Syndrome, patients potentially requiring immediate surgery for CD will be not included into the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Treatment of active, moderate Crohn’s disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: Rifaximin-EIR
Product Code: NA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 380-420

Primary Outcome(s)

Secondary Objective: To evaluate the effect of Rifaximin-EIR, administered at a daily dosage of 1,600 mg (2 x 400 mg tablet twice a day) for three months in patients with a moderately active Crohn's disease in terms of: • Changes in the expression and function of nuclear Pregnane-X-Receptor (PXR) and PXR metabolic and inflammatory target genes, • Correlation between the induced changes in the expression and function of PXR and PXR target genes and clinical and/or endoscopic response to Rifaximin-EIR treatment.

Timepoint(s) of evaluation of this end point: The primary endpoints will be evaluated at the end of the treatment period (3 months)

Main Objective: To evaluate the effect of Rifaximin-EIR, administered at a daily dosage of 1,600 mg (2 x 400 mg tablet twice a day) for three months in patients with a moderately active Crohn's disease in terms of clinical response and correlation with endoscopic improvement to Rifaximin-EIR treatment.

Primary end point(s): 1. The proportion of patients achieving a clinical response, defined as a CDAI reduction of = 70 points from baseline value at the end of treatment; 2. The proportion of patients achieving an endoscopic improvement, defined as the achievement of a one-class change (e.g. from moderately active to mildly active) in the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD); 3. The proportion of patients achieving a clinical response and endoscopic improvement.

Secondary Outcome(s)

Secondary end point(s): 1. To evaluate the effect of Rifaximin-EIR (Extended Intestinal Release; 2 x 400 mg tablet twice a day, total daily dose = 1600 mg) treatment in patients with active moderate Crohn’s disease on the expression and function of nuclear PXR and PXR metabolic and inflammatory target genes. 2. To evaluate whether there is a correlation between the induced modulation of PXR and PXR target genes and clinical response (defined as a Crohn’s Disease Activity Index - CDAI reduction of = 70 points from baseline value at the end of treatment) and/or endoscopic improvement (defined as the achievement of a one-class change in SES-CD) induced by Rifaximin-EIR treatment.

Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated at the end of the treatment period (3 months)

Secondary ID(s)

RETIC-PD/006/2011

Source(s) of Monetary Support

Alfa Wassermann Spa