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    Summary
    EudraCT Number:2012-001601-24
    Sponsor's Protocol Code Number:27018966IBS3002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-001601-24
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).
    A.4.1Sponsor's protocol code number27018966IBS3002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01553747
    A.5.4Other Identifiers
    Name:US INDNumber:79,214
    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 SponsorFuriex Pharmaceuticals
    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 supportFuriex
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointPrincipal Clinical Team Manager
    B.5.3 Address:
    B.5.3.1Street Address3900 Paramount Parkway
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560-7200
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1855235 9154
    B.5.5Fax number+1855235 9155
    B.5.6E-mailIBS3002@ashastd.org
    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 nameJNJ-27018966
    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 INNJNJ-27018966
    D.3.9.2Current sponsor codeJNJ-27018966
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 2
    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 nameJNJ-27018966
    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 INNJNJ-27018966
    D.3.9.2Current sponsor codeJNJ-27018966
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Diarrhea-predominant irritable bowel syndrome
    E.1.1.1Medical condition in easily understood language
    Irritable bowel syndrome
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10060845
    E.1.2Term Diarrhea predominant irritable bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    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 clinical response of patients with IBS-d to JNJ-27018966 relative to placebo.
    • To evaluate the overall safety and tolerability of JNJ-27018966 in the treatment of IBS-d.
    E.2.2Secondary objectives of the trial
    To further evaluate the treatment effect of JNJ-27018966 relative to placebo based on patient reports of IBS-d symptoms (abdominal pain, abdominal discomfort, abdominal bloating, stool consistency, global symptom scores, adequate relief), bowel functioning, and quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is a man or woman aged 18 to 80 years, inclusive, at Prescreening.
    2. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria as loose (mushy) or watery stools ≥ 25% and hard or lumpy stools <25% of bowel movements (see Appendix 6.2 of the protocol: Rome III Diagnostic Criteria for IBS for a definition of IBS and subtyping by predominant stool pattern).
    3. Patient has had a colonoscopy performed
    a. Within 10 years prior to Prescreening if patient is at least 50 years of age (alternatively, a sigmoidoscopy [preferably flexible], double contrast barium enema, or CT colonography within the past 5 years is acceptable [see recommendations of the American Cancer Society])
    b. Since the onset (if applicable) of any of the following alarm features for patients of any age (see Spiller and Thompson, 2010):
    i. Patient has documented weight loss within the past 6 months;
    ii. Patient has nocturnal symptoms;
    iii. Patient has a familial history of first-degree relatives with colon cancer (as noted by the American Cancer Society); or
    iv. Patient has blood mixed with their stool (excluding any blood from hemorrhoids).
    Note: Patients with any history of alarm features must have documentation within their medical record of the gastrointestinal work up performed.
    (Refer to protocol for criteria 4. to 12.)
    E.4Principal exclusion criteria
    1. Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria (see Appendix 6.2 of the protocol: Rome III Diagnostic Criteria for IBS for a definition of IBS and subtyping by predominant stool pattern).
    2. Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis) and celiac disease.
    3. Patient has a history of diverticulitis within 3 months prior to Prescreening.
    4. Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
    5. Patient has any of the following surgical history:
    a. Cholecystectomy with ANY history of post cholecystectomy biliary tract pain. Patients who had a successful cholecystectomy with no post operative biliary tract pain are candidates for the study;
    b. Any abdominal surgery within the 3 months prior to Prescreening;
    c. Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed).
    (Refer to protocol for criteria 6. to 35.)
    E.5 End points
    E.5.1Primary end point(s)
    While the designation of the relevant endpoints as primary and secondary within this protocol are based upon a potential NDA, the study is designed to also support potential marketing applications in other global regions. As such, endpoints designated as primary for the US FDA may be considered secondary by other regulatory agencies while endpoints designated as secondary for the US FDA may be considered primary by other regulatory agencies. To support a potential Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), pain responder status (designated as a secondary endpoint for the US FDA as described in Section E.5.2) and IBS global symptom responder status (designated as a secondary endpoint for the US FDA as described in Section E.5.2) will be considered co-primary efficacy endpoints.

    The primary efficacy endpoint is the composite responder status determined over the initial 12-week treatment period. A patient will be defined as a study composite responder if he or she meets the daily composite response criteria for at least 50% of days with diary entry during the interval from Weeks 1-12. A patient must meet BOTH of the following criteria on a given day for a daily response:
    • Pain response: worst abdominal pain score in the past 24 hours improved by ≥30% compared to the average in the week prior to randomization
    • Stool consistency response: BSS score <5 or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain
    To be eligible to be a responder, a patient must have a minimum of 60 days of diary entries over the interval from Weeks 1-12. Any patient with fewer than 60 days of diary entry will be considered a non-responder.

    For further details please refer to the protocol.

    Analysis of the primary endpoints will be elucidated in the statistical analysis plan.
    A separate statistical analysis plan will be developed to support a potential MAA to the EMA based on the alternatively designated co-primary efficacy endpoints.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    • Pain responders over the interval Weeks 1-4; Weeks 5-8; Weeks 9-12; Weeks 1-12; and Weeks 1-26: defined as those patients who meet the daily pain response criterion for at least 50% of days with diary entry during the interval. The daily pain response criterion is defined as worst abdominal pain score in the past 24 hours improved by ≥30% compared to the average in the week prior to randomization. To be eligible to be a responder, a patient must have a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days over the 26-week interval.

    • Stool consistency responders over the intervals from Weeks 1-4; Weeks 5-8; Weeks 9-12; Weeks 1-12 and Weeks 1-26: defined as those patients who meet the daily stool consistency response criterion for at least 50% of days with diary entry during the interval. The daily stool consistency response criterion is defined as BSS score <5 or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain. To be eligible to be a responder, a patient must have a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days over the 26-week interval.

    • IBS global symptom responders over the interval from Weeks 1-4; Weeks 5-8; Week 9-12; Weeks 1-12; and Weeks 1-26: defined as those patients who meet the daily IBS global symptom response criterion for at least 50% of days with diary entry during the interval. The daily IBS global symptom responder criterion is defined as an IBS global symptom score of 0 (none) or 1 (mild) or a daily IBS global symptom score improved by ≥2.0 compared to the average in the week prior to randomization. To be eligible to be a responder, a patient must have a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days over the 26-week interval

    • IBS-QoL responders: defined as patients who have achieved at least a 14 point improvement in IBS-QoL score. This definition applies to each timepoint of administration for the IBS-QoL total and subscale scores
    • IBS adequate relief responders over the interval from Weeks 1-12 and Weeks 1-26: defined as those patients with a weekly response of “Yes” to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval.

    Further secondary endpoints include:
    • Discomfort: changes from baseline in daily abdominal discomfort scores
    • Bloating: changes from baseline in daily abdominal bloating scores
    • Frequency: changes from baseline in number of bowel movements per day
    • Incontinence: changes from baseline in number of bowel incontinence episodes per day and number of incontinence-free days
    • Urgency: number of urgency episodes per day
    • IBS-QoL: total score and subscale scores compared to baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Multiple: daily, weekly, weeks 1-4, weeks 5-8, weeks 9-12, weeks 1-26
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 trial3
    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 concerned18
    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 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
    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
    Last patient, last visit. Patients will return to the clinic for a follow-up assessment at Wk 30 at the completion of the blinded withdrawal period. Patients who were discontinued from the study before Wk 30 should return to the study center to complete the early withdrawal assessments as soon as possible after stopping the study drug. At this study visit, patients will undergo the end-of-treatment/early withdrawal assessments and procedures listed in Appendix ‎6.1, Table ‎6–2 of the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 1125
    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)
    After the study is over, the study medication will not be available and the investigator will discuss future care with the individual.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Comprehensive Research Network/Primary Care Research Network
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-09
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