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    Summary
    EudraCT Number:2011-002821-24
    Sponsor's Protocol Code Number:RETIC-PD/006/2011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002821-24
    A.3Full title of the trial
    Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.
    Studio prospettico di farmacodinamica in pazienti con morbo di Crohn di grado moderato ed in fase attiva , trattati con Rifaximina-EIR compresse da 400 mg.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.
    Studio per valutare l' effetto del trattamento con Rifaximina-EIR compresse da 400 mg, in pazienti con morbo di Crohn di grado moderato ed in fase attiva.
    A.3.2Name or abbreviated title of the trial where available
    RETIC-PD/006/2011
    RETIC-PD/006/2011
    A.4.1Sponsor's protocol code numberRETIC-PD/006/2011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALFA WASSERMANN
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlfa Wassermann Spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlfa Wassermann SpA
    B.5.2Functional name of contact pointDirezione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street Addressvia Ragazzi del '99
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40133
    B.5.3.4CountryItaly
    B.5.4Telephone number0516489618
    B.5.5Fax number051-6489671
    B.5.6E-mailmgrimaldi@alfawassermann.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRifaximin-EIR
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIFAXIMIN
    D.3.9.1CAS number 80621-81-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodePRD52022
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number380 to 420
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of active, moderate Crohn’s disease
    Trattamento di pazienti con morbo di Crohn di grado moderato in fase attiva
    E.1.1.1Medical condition in easily understood language
    Treatment of active, moderate Crohn’s disease
    Trattamento di pazienti con morbo di Crohn di grado moderato in fase attiva
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Valutare l’effetto di Rifaximina-EIR somministrata alla dose giornaliera di 1600 mg (2 compresse da 400 mg due volte al giorno) per 3 mesi in pazienti con morbo di Crohn moderato in fase attiva in termini di risposta clinica e correlazione con un miglioramento del quadro endoscopico intestinale.
    E.2.2Secondary objectives of the trial
    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.
    Valutare l’effetto di Rifaximina-EIR somministrata alla dose giornaliera di 1600 mg (2 compresse da 400 mg due volte al giorno) per 3 mesi in pazienti con morbo di Crohn moderato in fase attiva in termini di: • Variazione dei livelli di espressione e della funzionalità del recettore X del pregnano (PXR) e di geni coinvolti nel metabolismo degli xenobiotici e dell’ infiammazione, • Correlazione tra variazione dei livelli di espressione genica di PXR e di geni coinvolti nel metabolismo degli xenobiotici e dell’ infiammazione e miglioramento del quadro clinico e/o endoscopico.
    E.2.3Trial contains a sub-study No
    E.3Principal 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).
    Lo studio coinvolgerà pazienti con morbo di Crohn moderato in fase attiva(CDAI ≥ 220 and ≤ 400), localizzato a livello della porzione ileo-colica o colica dell’intestino (con evidenza radiologica o endoscopica ottenuta almeno tre mesi prima del coinvolgimento nello studio).
    E.4Principal exclusion criteria
    Patients with symptoms attributed to Short Bowel Syndrome, patients potentially requiring immediate surgery for CD will be not included into the study.
    Verranno esclusi dallo studio, pazienti con sintomi attribuibili a sindrome dell’ intestino corto o quelli che necessitano di intervento chirurgico per morbo di Crohn.
    E.5 End points
    E.5.1Primary 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.
    1. Percentuale di pazienti con risposta clinica, definita come riduzione di almeno 70 punti dello CDAI alla fine del periodo di trattamento rispetto al valore al basale; 2. Percentuale di pazienti con miglioramento del quadro endoscopico intestinale, definito come variazione di una classe (es: da moderato a lieve), di Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD), 3. Percentuale di pazienti con risposta clinica e miglioramento del quadro endoscopico intestinale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints will be evaluated at the end of the treatment period (3 months)
    Gli endpoint primari verranno valutati alla fine del periodo di trattamento (3 mesi).
    E.5.2Secondary 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.
    1. Valutare l’effetto del trattamento con Rifaximina-EIR sui livelli di espressione, sulla funzionalità di PXR e di geni coinvolti nel metabolismo degli xenobiotici e dell’ infiammazione. 2. Valutare la correlazione tra la variazione dei livelli di espressione genica di PXR e di geni coinvolti nel metabolismo degli xenobiotici e dell’ infiammazione e la risposta clinica (riduzione di almeno 70 punti dello CDAI rispetto al valore al basale) e/o un miglioramento del quadro endoscopico intestinale (variazione di una classe di SES-CD).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated at the end of the treatment period (3 months)
    Gli endpoint secondari verranno valutati alla fine del periodo di trattamento (3 mesi).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-02-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard treatment and care for the disease and its severity
    Trattamenti e assistenza standard per la tipologia ed il grado di attività della malattia.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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