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NCT03449147 · ClinicalTrials.gov registry record · Phase 3

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

A Phase 3 study, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 3
Development phase
1,317
Enrollment target

NCT03449147: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.

NCT03449147 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,317 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03449147, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 3
Development phase
1,317 participants
Enrollment target

Study Summary

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Gefapixant 15 mg BID
  • DRUG Gefapixant 45 mg BID

Trial Details

FieldValue
Enrollment Target 1,317 participants
Start Date 2018-03-15
Est. Completion 2020-10-30
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the finished NCT03449147 record still lists

NCT03449147 is an interventional study that assigns participants to a tested intervention. Its 1,317 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03449147 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03449147 about?

NCT03449147 is a clinical study titled "A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)". The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo i...

What is the current status of trial NCT03449147?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,317 participants. The study started on 2018-03-15. Estimated completion is 2020-10-30.

What interventions are being tested in trial NCT03449147?

The interventions under investigation include: Placebo (DRUG), Gefapixant 15 mg BID (DRUG), Gefapixant 45 mg BID (DRUG).

Who is sponsoring clinical trial NCT03449147?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03449147's enrollment target sits among peer trials

1,317 185th of 2000 higher than 1,816 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03449147, the US trial registry maintained by the National Library of Medicine. NCT03449147 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.