CTRI/2025/06/089453尚未招募3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Patients with Chronic Cough
Sun Pharma Laboratories Limited SPLL13 个研究点 分布在 1 个国家目标入组 438 人开始时间: 2025年5月7日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 438
- 试验地点
- 13
- 主要终点
- Change from Baseline in the Leicester Cough Questionnaire (LCQ) total score with Gefapixant
研究概览
简要总结
This is a randomized, parallel-group, prospective, multicenter, double-blind, two-arm, placebo-controlled, Phase 3 comparative study. The study will be conducted at approximately 15-20 centers in India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and EC approval.
After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment.
After confirming the eligibility, patients will be randomized by allotting the randomization number. Patients will be either randomized to Test arm (Gefapixant 45 mg Tablets) OR to Comparator arm (Matching Placebo tablets for Gefapixant).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex, aged 18 to 65 years and ready to give written informed consent to participate in the study.
- •2.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 to the satisfaction of the Investigator/qualified designee prior to randomization.
- •3.Patient having a Computerised Tomography (CT) scan of thorax (within 1 year of Screening and after the onset of chronic cough) not demonstrating any clinically significant abnormality contributing to the chronic cough or any other clinically significant respiratory disease, in the opinion of the Investigator 4.Patient with chronic cough (defined as duration of more than 8 weeks after onset of cough symptoms) for less than 12 months prior to the screening visit (i.e., less than 14 months after onset of cough symptoms), based on documented medical history of patients.
- •5.Patient with diagnosis of refractory chronic cough or unexplained chronic cough as per the current American College of Chest Physicians (ACCP) guidelines 6.Women of childbearing potential (WOCP) must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till 2 weeks after the last dose of the study medication.
排除标准
- •1.Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes or history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs 2.Patient having a force expiratory volume (FEV1) /forced vital capacity (FVC) ratio less than 60%.
- •3.Patient with a history of upper or lower respiratory tract infection or recent clinically significant change observed in pulmonary status within 4 weeks of screening.
- •4.Patient with history of chronic bronchitis.
- •5.Patient who has previously received Gefapixant or other P2X purinocepter 3 (P2X3) antagonists.
- •6.Patient is currently enrolled in an investigational drug or device study.
- •7.Patient with history of participation in another clinical trial in the past 6 months prior to screening or planning to participate during the study 8.Patients with any clinically significant laboratory abnormalities/condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements 9.Patient with any surgery or medical procedure planned during the screening, treatment or follow-up periods 10.Pregnant, lactating women or women who intend to conceive or women of childbearing age who are not willing to use an acceptable method of birth control during the study period.
结局指标
主要结局
Change from Baseline in the Leicester Cough Questionnaire (LCQ) total score with Gefapixant
时间窗: Change from Baseline in the Leicester Cough Questionnaire (LCQ) total score with Gefapixant | relative to placebo assessed at Week 12 (2-week recall period)
relative to placebo assessed at Week 12 (2-week recall period)
时间窗: Change from Baseline in the Leicester Cough Questionnaire (LCQ) total score with Gefapixant | relative to placebo assessed at Week 12 (2-week recall period)
次要结局
- Change from Baseline in the Cough Severity VAS score(Weeks 4, 8, and 12)
- Incidence of TEAEs and SAEs(Throughout the study period)
- Change from Baseline in the LCQ total score(Weeks 4 and 8 (2-week recall period))
- Patient Global Impression of Change scale response(Weeks 4, 8, and 12)
研究者
研究点 (13)
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