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    Summary
    EudraCT Number:2013-000357-41
    Sponsor's Protocol Code Number:APC040
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-06-19
    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 ConcernedIreland - HPRA
    A.2EudraCT number2013-000357-41
    A.3Full title of the trial
    Identification of the Microbiota Dependent Response to Rifaximin in Irritable Bowel Syndrome Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Identification of the Microbiota (Gut Flora) Dependent Response to Rifaximin in Irritable Bowel Syndrome Patients
    A.4.1Sponsor's protocol code numberAPC040
    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 SponsorThe Alimentary Pharmabiotic Centre, University College Cork
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportScience Foundation Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Alimentary Pharmabiotic Centre, University College Cork
    B.5.2Functional name of contact pointDr. Susan Rafferty-McArdle
    B.5.3 Address:
    B.5.3.1Street Address5.05 BioSciences Institute, University College Cork
    B.5.3.2Town/ cityCork
    B.5.3.3Post code0
    B.5.3.4CountryIreland
    B.5.4Telephone number+353214901753
    B.5.6E-mailS.Rafferty@ucc.ie
    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 Normix
    D.2.1.1.2Name of the Marketing Authorisation holderAlfa Wassermann
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.9.3Other descriptive nameNormix
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibiotic
    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
    Irritable Bowel Syndrome
    E.1.1.1Medical condition in easily understood language
    Irritable Bowel Syndrome - IBS
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Identification of a microbial signature associated with Responders versus Non Responders to treatment with Rifaximin.

    (Response is defined as improved IBS symptoms which will be measured using an IBS symptom severity score and food frequency questionnaires between visits.)
    E.2.2Secondary objectives of the trial
    Identification of microbiome changes that are associated with an alleviation of symptoms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18 and < 65 at the time of the screening visit.
    2. IBS as defined by Rome III criteria.
    3. Clinical laboratory tests at screening showing no clinically significant abnormalities in the opinion of the Investigator.
    4. Signed and dated written informed consent prior to admission to the study.
    5. Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
    6. Female subject is currently either of:
    • non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses)
    OR
    • child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative pregnancy test both at screening (serum -HCG negative) and baseline (urine) prior to investigational product administration at visits 2, follow up on visits 3 and 4. The subject must also agree to one of the following methods of contraception:
    i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or,
    ii. Has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or,
    iii. Sexual partner(s) is/are exclusively female or,
    iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception until the end of their oral contraceptive pill packet following discontinuation of study medication).
    v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or,
    vi. Use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study.
    E.4Principal exclusion criteria
    1. As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
    2. Subjects who are pregnant or nursing.
    3. Evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but not limited to):
    Current evidence, or history of (at any time in the past);
    • inflammatory bowel disease (Crohn's disease or ulcerative colitis)
    • Lactose intolerance, not on a stable diet
    • Celiac Disease
    • laxative abuse (in the clinical judgement of the physician)
    • gastrointestinal surgery (exceptions include 6 months post-surgery for appendectomy, cholecystectomy, fundoplication without gas bloat, or hiatal hernia repair; 3 months post-surgery for herniorrhaphy without bowel resection)
    • gastroparesis
    • GI malignancy
    • carcinoid syndrome
    • amyloidosis
    • chronic pancreatitis
    • symptomatic gastrointestinal adhesions
    • toxic megacolon
    • gastrointestinal perforation
    • gastrointestinal obstruction and/or stricture.
    4. Current evidence of or occurrence within the past 6 months of:
    • diverticulitis
    • ileus
    • symptomatic cholelithiasis
    • proctitis.
    5. Subjects who have taken any medication for the treatment of IBS within 1 month prior to screening except for anti-diarrhoeal medications or laxatives for control of bowel habit which are allowed if at a stable dose for 2 weeks prior to randomisation.
    6. Subject is currently taking any prohibited medication, including antibiotics (within 3 month prior to screening)
    7. Subjects who are taking NSAIDs including aspirin on a regular basis or within 48 hours of a study day.
    8. Systemic or inhaled corticosteroids (Note: topical (e.g. nasal steroid) are allowed).
    9. The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
    10. History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
    11. Any other clinically significant laboratory abnormality.
    12. Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or in situ uterine cervix cancer that has been resected) within the previous 5 years.
    E.5 End points
    E.5.1Primary end point(s)
    The placebo effect in the IBS dataset is expected to affect 30% of the individuals.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For all end points at end of Trial.
    E.5.2Secondary end point(s)
    70% of the dataset of 80 IBS subjects is expected to provide a true biological signal
    E.5.2.1Timepoint(s) of evaluation of this end point
    For all endpoints at end of trial.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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
    Last visit of the last subject.
    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 months6
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state80
    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)
    Subjects are patients referrals from Gastroenterology Clinic Patients will continue to be followed up in Gastroenterology Clinic as per standard of care. Subjects responding to advertisment if medically required will be followed up in Gastroenterology clinic.
    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 Decision2013-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-03-18
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