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    Summary
    EudraCT Number:2013-000894-56
    Sponsor's Protocol Code Number:NAK-06
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-27
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-000894-56
    A.3Full title of the trial
    A 12-week double-blind, randomised, placebo-controlled, parallel group phase III study, followed by a 4-week randomised withdrawal period to evaluate the efficacy and safety of oral ibodutant 10 mg once daily in female patients with irritable bowel syndrome with diarrhoea (IBS-D).
    12týdenní, dvojitě zaslepená, randomizovaná, placebem kontrolovaná studie III. fáze s paralelními skupinami následovaná 4týdenním randomizovaným obdobím pro vystoupení s cílem vyhodnotit účinnost a bezpečnost perorálně podávaného přípravku ibodutant 10 mg jednou denně u pacientek trpících syndromem dráždivého tračníku s průjmem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical study assessing the treatment with ibodutant for Irritable Bowel Syndrome with diarrhoea.
    A.3.2Name or abbreviated title of the trial where available
    IRIS-3
    A.4.1Sponsor's protocol code numberNAK-06
    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 SponsorMenarini Ricerche S.p.A.
    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 supportMenarini Ricerche S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenarini Ricerche S.p.A.
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi, 1
    B.5.3.2Town/ cityFlorence
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 055 56809990
    B.5.5Fax number+390555680597
    B.5.6E-mailacapriati@menarini-ricerche.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 nameibodutant
    D.3.2Product code MEN15596
    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 INNibodutant
    D.3.9.1CAS number 522664-63-7
    D.3.9.2Current sponsor codeMEN 15596
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 with diarrhoea (IBS-D) in female patients.
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal disorder mainly characterised by abdominal pain and diarrohea and, hence, called irritable bowel syndrome with Diarrhoea (IBS-D), in female patients.
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10060849
    E.1.2Term Diarrhoea predominant irritable bowel syndrome
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10060845
    E.1.2Term Diarrhea 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 ibodutant on IBS symptoms as compared to placebo in IBS-D female patients over a 12 week oral treatment period.
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of ibodutant on 12 and 16-week treatment course with oral 10 mg dose once daily in IBS-D female patients.

    • To evaluate the rebound effect on IBS symptoms in IBS-D female patients after treatment discontinuation.

    • To evaluate ibodutant population pharmacokinetics in IBS-D female patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female patients aged 18 years or older.
    - Clinical diagnosis of IBS-D according to the following symptoms-based criteria as per Rome III modular questionnaire criteria:
    recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
    symptom-onset at least 6 months prior to diagnosis.
    loose or watery stools at least 25% of the time in the last 3 months AND hard or lumpy stools less than 25% of the time in the last 3 months.
    additional criterion: more than 3 bowel movements per day at least 25% of the time in the last 3 months.
    - For patients older than 50 years OR patients with a positive family history of colorectal cancer: normal results from colonoscopy/flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before the start of the Screening period.
    - For patients aged 65 years or older: absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal (GI) disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 6 months before the start of the Screening period.
    - Patient is willing to refrain from using any anti-diarrhoeal loperamide within 3 days prior to Run-in Visit and during the Run-in period (to be re-checked prior to randomisation).
    At the end of Run-in period, ONLY patients meeting the following e-diary criteria and all the other inclusion criteria will be eligible to progress to randomisation:
    - Patient has during both weeks of the Run-in period a weekly average of worst abdominal pain in the past 24 hours with a score of ≥3.0 on a 0 to 10 point scale (Abdominal Pain Intensity).
    - Patient has during both weeks of the Run-in period at least one bowel movement on each day.
    - Patient has during both weeks of the Run-in period a weekly average of at least 3 bowel movements per day.
    - Patient has during both weeks of the Run-in period at least one stool with a consistency of Type 6 or Type 7 according to the Bristol Stool Scale (BSS) on at least 2 days per week (Stool Consistency).
    - Patient has during both weeks of the Run-in period less than 2 bowel movements with a consistency of Type 1 or Type 2 according to the BSS per week.
    - Adequate compliance with the e-diary recording procedure defined as at least 11 of 14 days (≥75%) of the nominal daily data entry considering the last consecutive 14 days prior the randomisation [NOTE: Run-in duration is 14 days (+3 days)].
    E.4Principal exclusion criteria
    NOTE: Patients with any alarm signs (e.g. fever, rectal bleeding other than haemorrhoids, unintentional weight loss, anaemia) deserve special consideration to exclude any organic GI disease.
    - Male gender.
    - Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS according to the Rome III criteria.
    - Patient has had surgery that meets any of the following criteria:
    a)colonic or major abdominal surgery, i.e. bariatric surgery and stomach, small/large bowel or large vessel abdominal surgery (except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery).
    b)Any other major abdominal surgery in the previous 6 months.
    - Patient has any elective major surgery planned or expected at any time during the study.
    - Patient has a history of inflammatory bowel diseases, complicated diverticulosis (i.e. diverticulitis), ischaemic colitis, microscopic colitis.
    - Patient has a history of organic abnormalities of the GI tract, intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aortoiliac disease).
    - Patient has a history of pancreatitis of any etiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
    - Patient has an active biliary duct disease or a history of Sphincter of Oddi dysfunction.
    - Patient has a history of gluten enteropathy.
    - Patient has a history of lactose intolerance as assessed by response to diet.
    - Patient has a current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas and cervical carcinoma in situ).
    - Patient has a history of ectopic endometriosis.
    - Patient has a history of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
    - Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. NOTE: dietary habits, lifestyle and exercise regimen should be maintained for the duration of the study.
    - Use of prohibited concurrent medication within the previous month, namely: Antibiotics (4 months in the case of rifaximin); 5-HT3 antagonist alosetron.
    - Use of prohibited concurrent medication in the previous 7 days namely (see protocol for details): Antimuscarinic drugs; Drugs enhancing GI motility such as prokinetic agents and other stimulants of GI contractility drugs, laxatives, or anti-diarrhoeal agents (except for loperamide, please refer to inclusion criterion No.12); Analgesic drugs (opioids or non-steroidal anti-inflammatory drugs). NOTE: short term use of paracetamol is allowed for max 2 consecutive days; Fibre products and herbal preparations; Antidepressants; Benzodiazepines.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    Weekly response for abdominal pain intensity AND stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). The patient will be considered a weekly responder if she meets BOTH of the following criteria in the same week:
    Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline (2-week Run-in period);
    NOTE: “Worst abdominal pain score in the past 24 hours” hereafter will be called “abdominal pain intensity”.
    Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline (2-week Run-in period).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly response over 12 weeks of treatment.
    E.5.2Secondary end point(s)
    • Weekly response for abdominal pain intensity over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). The patient will be considered a weekly responder as defined in the primary endpoint in terms of abdominal pain intensity.
    • Weekly response for stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). The patient will be considered a weekly responder as defined in the primary endpoint in terms of stool consistency.
    • Weekly abdominal pain responder, defined as a patient with a decrease versus baseline (2-week Run-in period) of at least 30 % in the weekly average of abdominal pain intensity from Randomisation until the end of week 12. Additionally the same endpoint will be considered with the thresholds of 40% and 50%.
    • Weekly stool consistency responder defined as a patient with a decrease versus baseline (2-week Run-in period) of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 from Randomisation until the end of week 12.
    • Weekly Response for relief of overall IBS signs and symptoms over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to “Completely relieved/improved” or “Considerably relieved/improved”.
    • Evaluation of rebound effect by comparison between average abdominal pain intensity and stool consistency during the 4-week RW treatment period and baseline (2-week Run-in period) in patients who are re-randomised to placebo after being treated with ibodutant.
    • Change in IBS-SSS from baseline (Visit 3) after 12-week double-blind treatment period and 4-week RW treatment period.
    • Change of weekly average for each week during the 12-week double-blind treatment period and the 4-week RW treatment period versus baseline (2-week Run-in period) of specific symptoms of IBS-D i.e.:
    -Abdominal pain intensity.
    -Abdominal discomfort intensity.
    -Abdominal bloating intensity.
    -Stool urgency intensity.
    -Stool incontinence episodes.
    -Stool frequency.
    -Abdominal pain-free days.
    -Stool consistency score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    weekly or as per protocol.
    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 Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    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
    Bulgaria
    Czech Republic
    France
    Germany
    Italy
    Poland
    Romania
    Russian Federation
    Spain
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 207
    F.4.2.2In the whole clinical trial 535
    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)
    At the end of participation in the trial, the patient may resume/start any IBS-medication according to the Investigator’s recommendation as per standard of care.
    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 Decision2014-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-22
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