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    Summary
    EudraCT Number:2014-001644-38
    Sponsor's Protocol Code Number:RECD3125
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-09-18
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2014-001644-38
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.
    A.4.1Sponsor's protocol code numberRECD3125
    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 SponsorSalix Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportSalix Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSalix Pharmaceuticals, Inc
    B.5.2Functional name of contact pointRegulatory Affairs.
    B.5.3 Address:
    B.5.3.1Street Address8510 Colonnade Center Drive
    B.5.3.2Town/ cityRaleigh, North Carolina,
    B.5.3.3Post code27615
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019198621055
    B.5.5Fax number0019192284255
    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 Delayed Release (DR)
    D.3.4Pharmaceutical form 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 codeRifaxmin DR
    D.3.9.4EV Substance CodeSUB10312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of active Crohn’s disease
    E.1.1.1Medical condition in easily understood language
    Treatment of active Crohn’s disease
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of Rifaximin DR 800 mg BID vs. placebo for the induction of clinical remission and endoscopic
    response following 16 weeks of treatment in subjects presenting with active moderate Crohn’s disease.
    E.2.2Secondary objectives of the trial
    - To evaluate clinical and endoscopic remission following an additional 36-week Long Term Treatment Phase of Rifaximin DR 800 mg BID vs. placebo.
    -Assess the safety of Rifaximin DR following a 16-week induction, and an additional 36- week Long Term Treatment Phase (i.e., up to 52 weeks of treatment for eligible subjects).
    - Assess the population pharmacokinetics of Rifaximin DR.
    - Characterize the gastrointestinal microbiota from stool samples, and antibiotic resistance from bacteria cultured from stool samples before and after treatment with Rifaximin DR.
    - Evaluate the effects of Rifaximin DR treatment on indices of health outcomes.
    - Assess the effects of Rifaximin DR treatment on biological (inflammatory) markers of disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is 18 years of age at screening.
    - Subject is male or female.
    - Females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study.
    - Subject has moderate, non-fistulizing Crohn's disease in the ileum and/or colon as defined by a CDAI score of ≥ 220 and ≤ 450 points prior to randomization; and a SESCD score of ≥7. The SES-CD score will be calculated using the baseline ileocolonoscopy performed during the Screening Period.
    - During the Screening Period, the subject has the following average abdominal pain and average number of liquid/very soft stools:
     An average daily score of > 1.5 for abdominal pain (from CDAI Item 2), and
     An average daily count of > 1.5 for liquid/very soft stools (from CDAI Item 1).
    - Liquid/very soft stool will be defined as a consistency of Type 6 or Type 7 on the BSFS.
    - Subject is capable of understanding the requirements of the study, is willing to comply with all study procedures, and demonstrates ability to comply with the study electronic systems (including access to Wi-Fi) required to record Crohn's disease symptoms and CDAI components.
    - Subject understands the language of the informed consent form (ICF), and is capable and willing to sign the informed consent form.
    E.4Principal exclusion criteria
    -Subject has a diagnosis of ulcerative or indeterminate colitis.
    -Subject has a diagnosis of Celiac Disease.
    -Subject has had bowel surgery within 12 weeks prior to screening
    and/or has surgery planned or deemed likely for Crohn's disease during the study period.
    -Subject has had more than one segmental colonic resection.
    -Subject has presence of an ileostomy or colostomy.
    -Subject has known fixed symptomatic stenosis/stricture of the small or large bowel.
    -Subject has had more than 3 small bowel resections, or symptoms associated with short bowel syndrome.
    -Subject has current evidence of peritonitis.
    -Subject had history or evidence of colonic mucosal dysplasia.
    -Subject had history or evidence of adenomatous colonic polyps that have not been removed.
    -Subject has evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH) as well as liver function tests (LFTs) with values ≥ 1.5 times the upper limit of normal (ULN) for any of the following LFTs: alanine aminotransferase (ALT), aspartate aminotransferase
    (AST), alkaline phosphatase, or bilirubin at Screening.
    -Subject has diabetes (Type 1 or 2) that is poorly controlled in the opinion of the investigator, or has had an HbA1c 12% within 3 months prior to Screening or at the Screening Visit
    -Subject has history of the following conditions per Diagnostic and Statistical Manual of Mental Disorders, 5th edition:
    a major psychiatric disorder (including major depression or psychosis) alcohol or substance abuse within 24 months prior to signing the informed consent
    -Subject has a history of seizure disorders.
    -Subject has renal disease manifested by elevations in serum creatinine and/or blood urea nitrogen concentrations of ≥1.5 times the ULN.
    -Subject has unstable cardiovascular or pulmonary disease, categorized by a worsening in the disease condition that requires a change in treatment or medical care within 30 days prior to randomization.
    -Subject has an active malignancy within the last 5 years.
    -Subject has donated blood or blood products within the past 4 weeks prior to randomization.
    -Subject has known varicella, herpes zoster, or other severe viral infection within 6 weeks of randomization.
    -Subject has known human immunodeficiency virus (HIV) infection.
    -Subject has a positive stool test for Yersinia enterocolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or Clostridium difficile.
    -Subject has a history of tuberculosis infection and/or has received treatment for a tuberculosis infection. If subject has had a previous positive test for tuberculosis antigen then they must have a current negative chest X-ray to be eligible.
    -Subject used any biologic within 12 weeks prior to randomization.
    -Subject is unwilling to be tapered off corticosteroids by Week 8 of the Treatment Period or the subject is known by the Investigator to be steroid dependent.
    -Subject used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization.
    -Subject used any oral or intravenous antibiotic including rifaximin, rifampin or any drugs in the rifamycin group, within 4 weeks prior to the screening visit.
    -Subject had rectal administration of 5-ASA or corticosteroid enemas/foams/suppositories within 2 weeks prior to screening visit.
    -Subjects used tube or enteral feeding, an elemental diet, or parenteral alimentation within 2 weeks prior to Screening Visit. Note: dietary supplements (e.g. Boost, Ensure) are allowed.
    -Subjects who are planning to begin taking probiotics or similar supplements at or after the Screening Visit, or subjects who began using these supplements within 2 weeks prior to the Screening Visit.
    -Subject is currently receiving warfarin or other 4-hydroxycoumarins at the Screening Visit, or has plans to initiate the medication at any time during the study.
    -Subject, if female, is currently pregnant or has plans to become pregnant at any time during the study, has a positive pregnancy test at screening or is breastfeeding.
    -Subject has a history of sensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of Rifaximin DR.
    -Subject has used any investigational product within 30 days prior to randomization, or during the study.
    -Subject has any concurrent illness, disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    - Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1); AND (2) an abdominal pain rating of ≤ 1(from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit.

    - Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained between Week 16 and Week 17. SES-CD scores will be calculated from centrally-read digital video of ileocolonoscopies performed at baseline and between Week 16 and Week 17.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between week 16 and Week 17.
    E.5.2Secondary end point(s)
    - Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1); AND (2) an abdominal pain rating of ≤ 1(from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit.
    -Endoscopic remission defined as a SES-CD score of ≤ 2 at Week 52. SES-CD scores will be calculated from centrally-read digital video of ileocolonoscopies performed at Week 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Poland
    Russian Federation
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 314
    F.4.2.2In the whole clinical trial 660
    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)
    Subject will return to the care of their personal doctor.
    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 Decision2014-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-08-16
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