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Chronic CoughPhase 3NCT03696108

A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

A Phase 3 study testing Gefapixant in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 61 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the safety of two doses of gefapixant (MK-7264) in Japanese adult participants with refractory or unexplained chronic cough. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Cough
What is being tested?
Gefapixant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
61 sitesJapan
Study dates
31 Oct 2018to 7 Oct 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chest radiograph or computed tomography scan of the thorax not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator.
  • Chronic cough for ≥ 4 months and a diagnosis of refractory or unexplained chronic cough.
  • Persistent cough, despite treatment in accordance with the latest guideline of cough from the Japanese Respiratory Society, cough is a burden to the participant, and needs further treatment.
  • If female, is not pregnant, not breast-feeding, and either is not a woman of childbearing potential or agrees to follow the contraceptive guidance.

Who cannot join

  • Current smoker, or has given up smoking within 12 months of Screening.
  • History of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status.
  • Has a history of chronic bronchitis.
  • Current use of an angiotensin converting enzyme inhibitor (ACEI) or has taken an ACEI within 3 months of Screening.
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 OR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Visit 1).
  • History of malignancy ≤ 5 years.
Show all 12Show fewer
  • User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
  • Systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg at Screening.
  • History of cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs.
  • Known allergy/sensitivity or contraindication to gefapixant.
  • Donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant.
  • Previously received gefapixant or is currently participating in or has participated in an interventional clinical study.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

Japan61 sites

  • Akita University Hospital ( Site 3851)

    Akita, 010-8543

  • Fukuoka University Chikushi Hospital ( Site 3886)

    Chikushino-shi, Fukuoka, 818-8502

  • Fujisawa City Hospital ( Site 3891)

    Fujisawa, Kanagawa, 251-8550

  • Fukui-ken Saiseikai Hospital ( Site 3874)

    Fukui, 918-8503

  • Gifu Prefectural General Medical Center ( Site 3824)

    Gifu, 500-8717

  • Tokyo Medical University Hachioji Medical Center ( Site 3911)

    Hachiōji, Tokyo, 193-0998

  • JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)

    Hamamatsu, Shizuoka, 430-8525

  • Hamamatsu Medical Center ( Site 3866)

    Hamamatsu, Shizuoka, 432-8580

  • National Hospital Organization Tenryu Hospital ( Site 3823)

    Hamamatsu, Shizuoka, 434-8511

  • National Hospital Organization Mito Medical Center ( Site 3846)

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Kawaguchi Respiratory Clinic ( Site 3890)

    Higashiosaka, Osaka, 577-0843

  • Terada Clinic Respiratory Medicine & General Practice ( Site 3907)

    Himeji, Hyōgo, 670-0849

  • Kinki Central Hospital ( Site 3910)

    Itami, Hyōgo, 664-8533

  • Tochigi Takao Clinic ( Site 3833)

    Kagoshima, 890-0073

  • Ishikawa Prefectural Central Hospital ( Site 3915)

    Kanazawa, Ishikawa-ken, 920-8530

  • Japan Community Health care Organization Kanazawa Hospital ( Site 3817)

    Kanazawa, Ishikawa-ken, 920-8610

  • Oishi Clinic ( Site 3818)

    Kasuya-gun, Fukuoka, 811-2310

  • Sugiura Clinic ( Site 3806)

    Kawaguchi, Saitama, 332-0012

  • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)

    Kawasaki, Kanagawa, 210-0852

  • Kishiwada City Hospital ( Site 3880)

    Kishiwada, Osaka, 596-8501

  • National Hospital Organization Tokyo National Hospital ( Site 3909)

    Kiyose, Tokyo, 204-8585

  • Kobe City Hospital Organization Kobe City Medical Center West Hospital ( Site 3868)

    Kobe, Hyōgo, 653-0013

  • Kiheibashi Otolaryngology ( Site 3828)

    Kodaira, Tokyo, 187-0044

  • National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)

    Koga, Fukuoka, 811-3195

  • Komatsu Municipal Hospital ( Site 3892)

    Komatsu, Ishikawa-ken, 923-8560

  • National Hospital Organization Matsue Medical Center ( Site 3848)

    Matsue, Shimane, 690-8556

  • Koyama Medical Clinic ( Site 3838)

    Matsumoto, Nagano, 390-0872

  • Matsusaka City Hospital ( Site 3825)

    Matsusaka, Mie-ken, 515-8544

  • Tohno Chuo Clinic ( Site 3883)

    Mizunami, Gifu, 509-6134

  • Nagano Red Cross Hospital ( Site 3859)

    Nagano, 380-8582

  • Nagaoka Red Cross Hospital ( Site 3877)

    Nagaoka, Niigata, 940-2085

  • Chubu Rosai Hospital ( Site 3839)

    Nagoya, Aichi-ken, 455-8530

  • National Hospital Organization Nagoya Medical Center ( Site 3898)

    Nagoya, Aichi-ken, 460-0001

  • Nagoya City University Hospital ( Site 3899)

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)

    Naka-gun, Ibaraki, 319-1113

  • Saiseikai Niigata Hospital ( Site 3831)

    Niigata, 950-1104

  • Oita Red Cross Hospital ( Site 3837)

    Ōita, 870-0033

  • Yamagata Clinic ( Site 3813)

    Ōita, 870-0921

  • Chibana Clinic ( Site 3809)

    Okinawa, 904-2143

  • Sasaki Naika Clinic ( Site 3872)

    Sakai, Osaka, 591-8037

  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3900)

    Sakai, Osaka, 591-8555

  • Idaimae Minamiyojo Int Clinic ( Site 3903)

    Sapporo, Hokkaido, 064-0804

  • Kindai University Hospital ( Site 3871)

    Sayama, Osaka, 589-8511

  • National Hospital Organization Shibukawa Medical Center ( Site 3843)

    Shibukawa, Gunma, 377-0280

  • Shimonoseki City Hospital ( Site 3902)

    Shimonoseki, Yamaguchi, 750-8520

  • Ito ENT Clinic ( Site 3816)

    Shizuoka, 420-0803

  • Kamei Internal Medicine and Respiratory Clinic ( Site 3904)

    Takamatsu, Kagawa-ken, 761-8073

  • Nihonbashi Egawa Clinic ( Site 3805)

    Tokyo, 103-0028

  • The Fraternity Memorial Hospital ( Site 3873)

    Tokyo, 130-8587

  • Showa University Hospital ( Site 3896)

    Tokyo, 142-8666

  • Ebisu Clinic Koukokukai Medical Corporation ( Site 3804)

    Tokyo, 150-0013

  • Kono Medical Clinic ( Site 3894)

    Tokyo, 157-0072

  • Medical Corporation Kouwakai Kouwa Clinic ( Site 3895)

    Tokyo, 170-0003

  • Tokyo Metropolitan Geriatric Hospital ( Site 3905)

    Tokyo, 173-0015

  • JA Toride Medical Center ( Site 3822)

    Toride, Ibaraki, 302-0022

  • National Hospital Organization Kasumigaura Medical Center ( Site 3844)

    Tsuchiura, Ibaraki, 300-8585

  • National Hospital Organization Minami-Okayama Medical Center ( Site 3901)

    Tsukubo-gun, Okayama-ken, 701-0304

  • Nagata Hospital ( Site 3815)

    Yanagawa, Fukuoka, 832-0059

  • Yokohama City Minato Red Cross Hospital ( Site 3906)

    Yokohama, Kanagawa, 231-8682

  • Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)

    Yokohama, Kanagawa, 234-8503

  • Kanagawa Cardiovascular and Respiratory Center ( Site 3908)

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Double-blind Clinical Study to Evaluate the Long-term Safety and Efficacy of MK-7264 in Japanese Adult Participants With Refractory or Unexplained Chronic Cough

The primary objective of this study is to evaluate the safety of two doses of gefapixant (MK-7264) in Japanese adult participants with refractory or unexplained chronic cough.

Conditions
Chronic Cough
Being tested
Gefapixant, Placebo
Medical subject headings
Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GefapixantDrug

    Also called MK-7264

    Gefapixant 15 mg or 45 mg tablet administered orally BID

  • PlaceboDrug

    Placebo matched to gefapixant 15 mg or 45 mg administered orally BID

Study groups in NCT03696108
Study groupRoleWhat they receive
Gefapixant 15 mg BIDExperimentalParticipants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks).
Receives: Drug: Gefapixant; Drug: Placebo
Gefapixant 45 mg BIDExperimentalParticipants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks).
Receives: Drug: Gefapixant; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced at Least One Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to 54 Weeks

  2. Number of Participants Who Discontinued Study Drug Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to 52 Weeks

Secondary outcomes (3)

  1. Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12

    The LCQ is a 19-item cough-specific health-related quality of life (HRQoL) questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model.

    Measured: Baseline, Week 12

  2. Change From Baseline in LCQ Total Score

    The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model at weeks 4, 8, 12, 24, 38 and 52 of treatment.

    Measured: Baseline, up to 52 Weeks

  3. Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score

    The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at weeks 4, 8, 12, 24, 38 and 52 of treatment.

    Measured: Baseline, Up to 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2018
  2. Study start31 Oct 2018
  3. Primary completion7 Oct 2020
  4. Study completion7 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696108
Sponsor's protocol ID
7264-038
Other IDs
MK-7264-038, 184154
Status last verified
Aug 2021
First submitted
3 Oct 2018
Last updated
1 Nov 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Niimi A, Sagara H, Kikuchi M, Arano I, Sato A, Shirakawa M, La Rosa C, Muccino D. A phase 3, randomized, double-blind, clinical study to evaluate the long-term safety and efficacy of gefapixant in Japanese adult participants with refractory or unexplained chronic cough. Allergol Int. 2022 Oct;71(4):498-504. doi: 10.1016/j.alit.2022.05.006. Epub 2022 Jun 23.

    PubMed 35752582

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gefapixant in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 61 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced at Least One Adverse Event (AE) (time frame: Up to 54 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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