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    Summary
    EudraCT Number:2013-002394-22
    Sponsor's Protocol Code Number:RFIB3053
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-05
    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 number2013-002394-22
    A.3Full title of the trial
    A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhoea (IBS-D)
    Studie zur Untersuchung der Wirksamkeit und Sicherheit einer Wiederholungsbehandlung mit Rifaximin 550 mg 3 x täglich bei Patienten mit Reizdarmsyndrom mit Diarrhö (IBS-D)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhoea (IBS-D)
    Studie zur Untersuchung der Wirksamkeit und Sicherheit einer Wiederholungsbehandlung mit Rifaximin 550 mg 3 x täglich bei Patienten mit Reizdarmsyndrom mit Diarrhö (IBS-D)
    A.3.2Name or abbreviated title of the trial where available
    Rifaximin IBS Study
    A.4.1Sponsor's protocol code numberRFIB3053
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01543178
    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 organisationTMC Pharma Services Ltd
    B.5.2Functional name of contact pointClinical and Regulatory Services
    B.5.3 Address:
    B.5.3.1Street AddressLodge Farm Barn, Elvetham Park Estate, Fleet Road
    B.5.3.2Town/ cityHartley, Wintney, Hants
    B.5.3.3Post codeRG27 8AS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441252842 255
    B.5.5Fax number00441252842 255
    B.5.6E-mailinfo@tmcpharma.com
    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 Yes
    D.2.1.1.1Trade name Xifaxan
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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
    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 codeRifaximin
    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 number550
    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
    Irritable bowel syndrome (IBS) is a heterogeneous gastrointestinal (GI) disorder characterized by frequent and debilitating symptoms (e.g. diarrhoea, bloating, abdominal pain, urgency to defecate, gas, faecal incontinence). A distinct feature of the disorder is the often cyclical waxing and waning of various symptoms. There remains a significant unmet need for effective and safe therapies, particularly for IBS with diarrhoea (IBS-D).
    E.1.1.1Medical condition in easily understood language
    Irritable Bowel Syndrome with Diarrhoea
    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 LLT
    E.1.2Classification code 10060849
    E.1.2Term Diarrhoea predominant irritable bowel syndrome
    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 evaluate the efficacy of repeat treatment with rifaximin 550mg TID in subjects with IBS-D who responded to initial treatment with rifaximin 550 mg TID.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of rifaximin 550 TID in subjects with IBS-D.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is 18 years of age
    2. Male or female
    Females of childbearing (reproductive) potential must have a negative pregnancy test at Screening/Treatment 1 Phase and agree to use an acceptable method of contraception throughout their participation in the study. Acceptable methods of contraception include:
    – hormonal methods (oral contraceptives, patches or medroxyprogesterone acetate)
    – an intrauterine device (IUD) with a documented failure rate of less than 1% per year.
    Abstinence may be considered an acceptable method of contraception at the discretion of the investigator.

    Females who have been surgically sterilized (e.g, hysterectomy or bilateral tubal ligation) or who are postmenopausal (total cessation of menses for > 1 year) will not be considered “females of childbearing potential”.
    3. Subject has IBS confirmed by the Rome III diagnostic criteria3 (below):
    Recurrent abdominal pain or discomfort** at least 3 days per month in the last 3 months, with symptom onset at least 6 months prior to diagnosis associated with 2 or more of the following:
    􀁸 Improvement with defecation;
    􀁸 Onset associated with a change in frequency of stool;
    􀁸 Onset associated with a change in form (appearance) of stool
    **Discomfort means an uncomfortable sensation not described as pain.
    4. During the Screening/Treatment 1 Phase (at least 7 and up to 13 days), the following
    average daily symptom scores for IBS are required in all categories for entry into the study:
    􀁸 An average score of greater than or equal to 3 for abdominal pain
    􀁸 An average score of greater than or equal to 3 for bloating
    􀁸 At least 2 days in a week with stool consistency of 6 (Fluffy pieces with ragged edges, a mushy stool) or 7 (Watery stool, no solid pieces; entirely liquid) using the BSS
    5. Subject may be included if they have had a documented colonoscopy within the past
    10 years (preferably including biopsies) as part of a workup for IBS-D. Subjects with a
    clinical diagnosis of IBS-D who are either (1) less than 50 years of age and have never had a colonoscopy or (2) whose last colonoscopy was greater than 10 years ago may be possible etiologies of the diarrhoea such as microscopic colitis and in the opinion of the investigator, the subject does not need a complete colonoscopy for other medical reasons.
    6. Subject must maintain a stable diet; including dietary supplements, vitamins and other nutraceuticals. Subject should not introduce any major lifestyle changes for the duration of the study (eg.: initiation or discontinuation of a high fibre or low carbohydrate diet)
    7. Subject is capable of understanding the requirements of the study, is willing to comply with all study procedures, understands the language of the informed consent form, and is capable and willing to sign the informed consent form.
    E.4Principal exclusion criteria
    A subject will be eligible for inclusion in this study if he/she meets any of the following
    criteria:
    1. Presents with Type 1 = Separate hard lumps, like nuts (hard to pass) or Type 2 = Sausage-shaped but lumpy (on the BSS) during the Screening/Treatment 1 Phase (for entry into Treatment 2 Phase)
    2. Subject has failed to record 7 days of the daily diary assessments during the
    Screening/Treatment 1 Phase (for entry into Treatment 2 Phase)
    3. Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, gastroesophageal reflux (GERD), or infectious gastroenteritis. Note: subjects with GERD controlled by stable (> 30 days) doses of medication or diet are eligible to participate in the study.
    4. Subject has a history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, celiac disease), GI malignancy, GI obstruction, gastroparesis, carcinoid syndrome, pancreatitis, amyloidosis, ileus or cholelithiasis. The subject is eligible to participate if they have had cholelithiasis and had a cholecystectomy greater than 6 months prior to signing the ICF.
    5. Subject has diabetes (Type 1 or Type 2)
    6. Subject requires GI surgery, has a history of GI surgery, or has had a polypectomy (open surgical or endoscopic) for which the histology showed it to be malignant. Subjects are excluded if they have had a cholecystectomy and/or abdominal hernia repair less than 6 months prior to signing the ICF. The subject is eligible to participate if they have had: a routine endoscopic
    polypectomy with benign histology, and/or an uncomplicated appendectomy with no
    history of post operative obstruction or symptomatic adhesions for at least 5 years prior to signing the ICF.
    7. Subject has lactose intolerance not controlled by a lactose free diet.
    8. Subject presents with symptoms of enteric infections including but not limited to Yersinia enterocolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or Clostridium difficile.
    9. Subject has history of a major psychiatric disorder (DSM-III-R or DSM-IV), including
    major depression, psychoses, alcohol or substance abuse within the past 24 months prior to signing the informed consent
    10. Subject has a history of seizure disorders
    11. Subject is pregnant, planning to become pregnant, or is lactating
    12. Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B or C)
    13. Subject has a history of abnormal thyroid function not controlled by thyroid medications
    14. Subject has hepatic disease manifested by twice the upper limit of normal (ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin)
    15. Subject has renal disease manifested by 1.5 times the ULN of serum creatinine or blood urea nitrogen levels
    16. Exclusion criteria #16 removed during Amendment 2
    17. 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 of signing the ICF
    18. Subject has any condition or circumstance that adversely affects the subject or could cause noncompliance with treatment or visits
    19. Subject has an active malignancy within the last 5 years (exceptions: basal cell carcinomas of the skin, or if female, in situ cervical carcinoma that has been surgically excised)
    20. Subject has participated in an investigational study within the 30 days prior to signing the ICF
    21. Subject is taking any products specifically marketed as probiotics (standard food or yogurt products are allowed) after initiating diary assessments
    22. Subject is taking products or foods containing sugar alcohols (including hydrogenated starch hydrolysates, isomalt, lactitol, maltitol, mannitol, sorbitol (e.g. sugar-free chewing gums or drinks) or xylitol (e.g. sugar-free hard candy, chewing gum, and many processed foods labelled “sugar-free”) after initiating diary assessments
    23. Subject is taking/has started a course of:
    􀁸 Antidepressants (within 6 weeks of signing the ICF, or if a change in dose or
    discontinuation of the drug during the course of the study is anticipated).
    􀁸 Anti-seizure and/or antipsychotic drugs (including those for bipolar disorder) within 4
    weeks of signing the ICF.
    24. Subject is currently taking and plans to continue taking antidiarrheals (e.g., loperamide and bismuth subsalicylate) after initiating diary assessments.
    25. Subject is taking rifaximin within 60 days or any other antibiotic within 14 days prior to
    signing the informed consent (ICF).
    26. Subject is taking antispasmodics, narcotics, prokinetic drugs, warfarin and other 4-hydroxycoumarins, lubiprostone, or drugs indicated for IBS (e.g., alosetron) after initiating diary assessments.
    27. Subject has biopsy proven diagnosis of microscopic colitis.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoint:
    Proportion of subjects who are responders to repeat treatment in both IBS-related abdominal pain AND stool consistency during the 4 week treatment-free follow-up (or Primary Evaluation Period [PEP]) in the Double Blind Repeat (DBR) Treatment Phase.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 2 to 6 of the 4 week follow up of Treatment 2 Phase
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints:
    􀁸 Proportion of subjects who are responders to repeat treatment in stool consistency during PEP in the DBR
    Treatment Phase.
    􀁸 Proportion of subjects who are responders to repeat treatment in IBS-related abdominal pain during PEP in the
    DBR Treatment Phase.
    􀁸 Proportion of subjects who are responders to repeat treatment in both IBS-related abdominal pain AND stool consistency with at least 1 point improvement in weekly average daily IBS symptoms compared to baseline during
    PEP in the DBR Treatment Phase.
    􀁸 Proportion of subjects who are responders to repeat treatment in IBS-related bloating during PEP in the DBR
    Treatment Phase.

    Safety Endpoints:
    􀁸 Incidence, intensity and type of adverse events (AEs)
    􀁸 Changes from baseline in laboratory parameters (haematology, clinical chemistry, urinalysis)
    􀁸 Changes from baseline in vital sign measurements
    􀁸 Changes from baseline in physical examination
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 Week follow-up phase (Primary Evaluation Period - PEP) of the Treatment 3 Phase (DBR Treatment Phase)
    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 No
    E.6.7Pharmacodynamic No
    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) 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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Germany
    United Kingdom
    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 years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days23
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 800
    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)
    Expected normal treatment of the condition
    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 Decision2013-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-18
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