Chronic CoughPhase 2NCT03482713
Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)
A Phase 2 study testing Gefapixant 45 mg in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 16 sites in Japan.
Trial summary
This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory 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 45 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 16 sitesJapan
- Study dates
- 16 Mar 2018to 7 Jun 2018
- Phase
- Phase 2
- 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 (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 disease in the opinion of the principal investigator or the sub-investigator.
- Has had chronic cough for ≥ 1 year and a diagnosis of refractory chronic cough or unexplained chronic cough.
- For female participants, is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
- Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)
Who cannot join
- Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with a pack-year history >20 pack-years
- Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status
- Has a history of chronic bronchitis
- Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
- Has a history of malignancy ≤5 years
- Has a screening systolic blood pressure >160 millimeters of mercury (mmHg) or a diastolic blood pressure >90 mm Hg
Show all 11Show fewer
- Has a history of cutaneous adverse drug reaction to sulfonamides with or without systemic symptoms or history of anaphylaxis to sulfonamides
- Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
- Has a known allergy/sensitivity or contraindication to gefapixant
- Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
- Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Fukushima Medical University Hospital ( Site 3338)
Fukushima, 960-1295
Kawaguchi Respiratory Clinic ( Site 3304)
Higashiosaka, Osaka, 577-0843
Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)
Hitachi-Naka, Ibaraki, 312-0057
Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)
Kakogawa, Hyōgo, 675-0101
Saiseikai Kanazawa Hospital ( Site 3337)
Kanazawa, Ishikawa-ken, 920-0353
Komatsu Municipal Hospital ( Site 3308)
Komatsu, Ishikawa-ken, 923-8560
Matsusaka City Hospital ( Site 3325)
Matsusaka, Mie-ken, 515-8544
Nagaoka Red Cross Hospital ( Site 3307)
Nagaoka, Niigata, 940-2085
Nagoya City University Hospital ( Site 3328)
Nagoya, Aichi-ken, 467-8602
Idaimae Minamiyojo Int Clinic ( Site 3321)
Sapporo, Hokkaido, 064-0804
Kamei Internal Medicine and Respiratory Clinic ( Site 3309)
Takamatsu, Kagawa-ken, 761-8073
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)
Tokyo, 101-0041
Nihonbashi Medical & Allergy Clinic ( Site 3334)
Tokyo, 103-0022
Fukuwa Clinic ( Site 3311)
Tokyo, 103-0027
Showa University Hospital ( Site 3331)
Tokyo, 142-8666
Yokohama City Minato Red Cross Hospital ( Site 3306)
Yokohama, Kanagawa, 231-8682
About this study
Official title: Phase II Study, Randomized, Double-Blind, Placebo-Controlled 4-Week Clinical Study, to Evaluate the Efficacy and Safety of MK-7264 in Adult Japanese Participants With Unexplained or Refractory Chronic Cough
This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic cough.
- Conditions
- Chronic Cough
- Being tested
- Gefapixant 45 mg, 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.
Gefapixant 45 mgDrug
Also called MK-7264
Gefapixant 45 mg (film-coated tablet) to be administered orally BID
PlaceboDrug
Placebo (film-coated tablet) matching gefapixant to be administered orally BID
| Study group | Role | What they receive |
|---|---|---|
| Gefapixant 45 mg | Experimental | Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days. Receives: Drug: Gefapixant 45 mg |
| Placebo | Placebo comparator | Participants will receive a film-coated placebo tablet matching gefapixant BID for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced an Adverse Event
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to 6 weeks
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to 4 weeks
Secondary outcomes (2)
Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour
Cough frequency will be evaluated using a digital recording device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. Change from baseline in log-transformed 24-hour coughs per hour = log (24-hour coughs per hour at post-baseline) - log (24-hour coughs per hour at baseline). The denominators may be different if the recording period is actually <24 hours but ≥20 hours).
Measured: Baseline and Week 4
Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour
Change from baseline at Week 4 in awake coughs per hour is the average hourly cough frequency (based on sound recordings) during the 24-hour monitoring period while the participant is awake. Change from baseline in log-transformed awake coughs per hour = log (awake coughs per hour at post-baseline) - log (awake coughs per hour at baseline) for the monitoring period the participant is awake.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start16 Mar 2018
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Japanese adult participants with refractory or unexplained chronic cough will be randomized to 1 of 2 treatment groups: gefapixant 45 mg twice daily (BID), or placebo BID.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482713
- Sponsor's protocol ID
- 7264-033
- Other IDs
- MK-7264-033, 183925
- Status last verified
- Oct 2019
- First submitted
- 16 Mar 2018
- Last updated
- 17 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study, Randomized, Double-Blind, Placebo-Controlled 4-Week Clinical Study, to Evaluate the Efficacy and Safety of MK-7264 in Adult Japanese Participants With Unexplained or Refractory Chronic Cough
- ClinicalTrials.gov ID
- NCT03482713
- Acronym / sponsor ID
- 7264-033
- Conditions
- Chronic Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Japanese adult participants with refractory or unexplained chronic cough will be randomized to 1 of 2 treatment groups: gefapixant 45 mg twice daily (BID), or placebo BID.
| Arm | Type | Receives |
|---|---|---|
| Gefapixant 45 mg | Experimental | Drug: Gefapixant 45 mgParticipants will receive a gefapixant 45 mg film-coated tablet BID for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a film-coated placebo tablet matching gefapixant BID for 28 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 disease in the opinion of the principal investigator or the sub-investigator.
- Has had chronic cough for ≥ 1 year and a diagnosis of refractory chronic cough or unexplained chronic cough.
- For female participants, is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
- Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)
Key exclusion criteria (11 listed)
- Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with a pack-year history >20 pack-years
- Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status
- Has a history of chronic bronchitis
- Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
- Has a history of malignancy ≤5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gefapixant 45 mgAlso: MK-7264Gefapixant 45 mg (film-coated tablet) to be administered orally BID | Drug | Gefapixant 45 mg |
| PlaceboPlacebo (film-coated tablet) matching gefapixant to be administered orally BID | Drug | Placebo |
Primary outcome
Number of Participants Who Experienced an Adverse Event
Time frame: Up to 6 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
Time frame: Up to 4 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
2 secondary outcomes
Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour
Time frame: Baseline and Week 4
Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour
Time frame: Baseline and Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefapixant 45 mg in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 16 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 11 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 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Jul 2019). 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 an Adverse Event (time frame: Up to 6 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?
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 17 Oct 2019.