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    Summary
    EudraCT Number:2019-002321-29
    Sponsor's Protocol Code Number:MK-7264-042
    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:2019-10-08
    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 number2019-002321-29
    A.3Full title of the trial
    A Phase 3b Randomized Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women with Chronic Cough and Stress Urinary Incontinence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Gefapixant in Women with Chronic Cough and Stress Urinary Incontinence
    A.4.1Sponsor's protocol code numberMK-7264-042
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.5.2Functional name of contact pointSusan Lu
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1732594-5766
    B.5.6E-mailsusan_lu@merck.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 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.3.2Product code MK-7264
    D.3.4Pharmaceutical form Film-coated 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 INNGEFAPIXANT
    D.3.9.1CAS number 1015787-98-0
    D.3.9.2Current sponsor codeMK-7264
    D.3.9.3Other descriptive nameMK-7264, AF-219 and RO4926219
    D.3.9.4EV Substance CodeSUB184344
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 placeboFilm-coated tablet
    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
    Chronic Cough and Stress Urinary Incontinence
    E.1.1.1Medical condition in easily understood language
    Chronic Cough and Stress Urinary Incontinence
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10066218
    E.1.2Term Stress urinary incontinence
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the efficacy of gefapixant (MK-7264) in reducing the frequency of cough-induced stress urinary incontinence (SUI) episodes compared to placebo as determined by a participant Incontinence Diary, measured as percentage change from baseline in episodes of cough-induced SUI at Week 12
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of gefapixant compared to placebo in percent of participants with adverse events (AEs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Chronic Cough
    1. Has a chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the principal investigator or subinvestigator.
    2. Has a chronic cough (defined as duration of >8 weeks after onset of symptoms) for ≥12 months.
    3. Has a diagnosis of refractory chronic cough or unexplained chronic cough.
    4. Meet a certain cough severity score at certain study visits.
    Stress Urinary Incontinence
    5. Has symptoms of SUI, defined as involuntary loss of urine on effort, physical exertion, or on sneezing or coughing, for ≥ 3 months.
    6. Has pure or predominant SUI, based on certain criteria
    7. Has a history of cough-induced SUI, based on certain criteria.
    8. Meets a certain number of cough-induced SUI episodes.
    9. Has a positive cough stress test at Screening/Visit 1.
    Demographics
    10. Is female, 18 years of age or older, at the time of signing the informed consent.
    11. Has a body mass index of ≤ 40 kg/m2.
    Female Participants
    Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    12. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    - Is not a woman of childbearing potential (WOCBP)
    OR
    - Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 2 weeks (14 days) after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
    Informed Consent
    13. Provides documented informed consent/assent for the study (or legally acceptable representative). The participant may also provide consent for future biomedical research.
    However, the participant may participate in the study without participating in future biomedical research.
    Study Participation
    14. Demonstrates compliance with diary completion requirements.
    15. Is willing and able to comply with all aspects of the protocol, including agreeing not to smoke during the study and demonstrating an ability to follow study procedures (including completion of the I-QoL, CSD, and Cough Severity VAS) to the satisfaction of the investigator/qualified designee prior to randomization.
    E.4Principal exclusion criteria
    1. Is a current smoker
    2. Has given up smoking within 12 months of Screening/Visit 1
    3. Is a former smoker with a smoking history greater than 20 pack-years
    4. Has a FEV1/ FVC ratio <60%
    5. Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status within 4 weeks of Screening/Visit 1
    6. Has a history of chronic bronchitis, defined as a cough that produces a clinically significant amount of sputum that occurs every day for at least 3 months in a row, with those periods occurring at least 2 years in a row
    7. Has a history of surgery to treat SUI within 1 year of the Screening/Visit 1
    8. Has a history of other specialized treatments for SUI, including intravesical balloon or urethral bulking agent therapy
    9. Has a pessary or other external incontinence device currently or within 1 month of the Screening/Visit 1
    10. Has a history of Grade 3 or higher pelvic organ prolapse previously documented or diagnosed on screening examination
    11. Has a neurogenic bladder
    12. Has unexplained hematuria or has dysuria at Screening/Visit 1
    13. Has a history of adult nocturnal incontinence
    14. Has a history of continuous urine leakage within 1 month of the Screening/Visit 1
    15. Has a history of interstitial cystitis
    16. Has a history of clinically significant neurological disease or injury that could affect the lower urinary tract or its nerve supply
    17. Has active or recurrent urinary tract infection
    18. Has a history of having a permanent urinary catheter or any urinary
    catheterization within 3 months of the Screening/ Visit 1
    19. Has an eGFR <30 mL/min/1.73 m2 at Screening/Visit 1 OR eGFR ≥30 mL/min/1.73 m2 and <50 mL/min/1.73 m2 at Screening/Visit 1 with unstable renal function
    20. Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
    21. Is, at the time of signing the informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
    22. Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs.
    23. Has a known allergy/sensitivity or contraindication to gefapixant or its excipients
    24. Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
    25. Is a WOCBP who has a positive urine pregnancy test at Screening/Visit 1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
    26. Requires treatment with a therapy for chronic cough that does not adhere to the guidance parameters for concomitant medication
    27. Is currently taking an angiotensin converting enzyme inhibitor or has taken an angiotensin converting enzyme inhibitor within 3 months of Screening/Visit 1
    28. Requires the following pharmacologic therapies that may impact bladder function, which are not allowed from 2 weeks prior to Screening/Visit 1 through completion of the study:
    - Alpha1-antagonists
    - H1-receptor antagonists
    29. Requires pharmacologic treatments that may impact bladder function, which are not allowed from 2 weeks prior to Visit 2 through the completion of the study. These therapies include, but are not limited to the following:
    -Serotonin–noradrenaline reuptake inhibitors
    -Anticholinergics
    -Smooth muscle relaxants
    -Tricyclic antidepressants
    -Alpha-adrenergic agonists
    -Beta-3 agonists
    -Botulinum toxins, including BOTOX® for the treatment of any bladder condition
    30. Requires non-pharmacologic treatments for incontinence which are not allowed from 1 month prior to Screening/Visit 1 through completion of the study
    31. Has previously received gefapixant or other P2X3 antagonists
    32. Is concurrently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days of participating in this current study
    33. Has significantly abnormal laboratory tests at Screening/Visit 1 including:
    - Alkaline phosphatase, ALT, AST >200% of the upper limit of normal, or bilirubin >150% of the upper limit of normal
    -Hemoglobin <10 g/dL, WBC <2500 mm3, neutrophil count <1500 mm3, platelet count <100 ×103/mm3
    For any of the above listed laboratory assessments, 1 repeat measurement will be allowed at the investigator’s discretion, before being considered a screen failure
    34. Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study
    35. Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    1. Percent change from baseline in average daily cough-induced stress urinary incontinence (SUI) episodes at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline, Week 12
    E.5.2Secondary end point(s)
    1. Percentage of participants with one or more adverse events (AEs)
    2. Percentage of participants who discontinue study drug due to an AE
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to ~Week 14
    2. Up to Week 12
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 EEA12
    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
    Guatemala
    Israel
    Korea, Republic of
    Peru
    Russian Federation
    Ukraine
    United States
    Germany
    Spain
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    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
    The overall study ends when the last participant completes the last study-related telephone-call or visit, withdraws from the study, or is lost to follow-up
    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 months5
    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 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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 380
    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)
    None
    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 Decision2020-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-02
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