Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04525885 | A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension | PHASE3 | COMPLETED | 161 | — | — | May 17, 2019 | Sep 15, 2022 | Jan 12, 2024 | 8 | China |
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).
| Arm | Type | Description |
|---|---|---|
| Gefapixant 45 mg BID | EXPERIMENTAL | Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). |
| Gefapixant 15 mg BID | EXPERIMENTAL | Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period. |
| Name | Type | Description |
|---|---|---|
| Gefapixant 45 mg twice daily (BID) | DRUG | Gefapixant 45 mg tablet to be administered orally BID |
| Gefapixant 15 mg BID | DRUG | Gefapixant 15 mg tablet to be administered orally BID |
| Placebo | DRUG | Placebo tablet administered orally BID |
| Gefapixant 45 mg BID | DRUG | Gefapixant 45 mg tablet to be administered orally BID |
Inclusion Criteria: * 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 dis...