MK-7264 PHASE 3 STUDY IN ADULT PARTICIPANTS WITH CHRONIC COUGH (PN027)

Not Applicable

Completed

• Conditions: -J398 Other specified diseases of upper respiratory tract; Other specified diseases of upper respiratory tract; J398

• Registration Number: PER-003-18
• Lead Sponsor: Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-16
• Study Completion: 2020-05-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified