EUCTR2019-002321-29-GB进行中（未招募）1 期
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 - Phase 3b Gefapixant for Chronic Cough and Stress Urinary Incontinence
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc0 个研究点目标入组 380 人开始时间: 2019年10月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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)
- •- 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 written informed consent for the study (or legally acceptable representative, if applicable). 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •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 for urinary incontinence, 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, i
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