A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MK-7264 IN ADULT PARTICIPANTS WITH CHRONIC COUGH (PN030)

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 62 人开始时间: 2018年4月6日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1.Women and men of at least 18 years of age
•2.Have chronic cough for ≥1 year and a diagnosis of refractory or unexplained chronic cough.
•3.Have a score of ≥40 mm on the Cough Severity VAS at both Screening and Baseline visits.
•4.If participant is female, she is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to follow the contraceptive guidance in protocol.
•5.The participant (or legal representative) provides written informed consent for the study.
•6.The participant is willing and able to comply with all aspects of the protocol.

•1.Current smoker or has given up smoking within 12 months of Screening.
•2.Former smokers with a pack/year history greater than 20 pack-years.
•3.History of upper or lower respiratory tract infection or change in pulmonary status within 4 weeks of Screening.
•4.History of chronic bronchitis occurring at least 2 years in a row.
•5.Currently taking an angiotensin converting enzyme inhibitor or has taken one within 3 months of Screening.
•6.Has a history of malignancy ≤5 years prior to signing informed consent
•7.User of recreational or illicit drugs or has recent history of drug or alcohol abuse or dependence
•8.Screening systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg at Screening.
•9.History of cutaneous adverse drug reaction to sulfonamides or history of anaphylaxis to sulfonamides.
•10.Has a known allergy/sensitivity or contraindication to MK-7264 or its excipients
•11.Requires treatment with a therapy that does not adhere to the protocol parameters.
•12.Has previously received MK-7264.
•13.Is currently participating in or has participated in an clinical study with an investigational compound or device within 30 days of Screening.
•14.Significantly abnormal laboratory tests at Screening

发起方

MERCK SHARP & DOHME PERU S.R.L.,