Acute CoughPhase 2NCT03569033
Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
A Phase 2 study testing Gefapixant in people with Acute Cough, run by Merck Sharp & Dohme LLC at 1 site in United Kingdom.
Trial summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute 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
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2018to 19 Nov 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health
- Susceptible to human rhinovirus type 16 (HRV-16)
- Male or non-pregnant and non-breast feeding female
- If female of reproductive potential, agrees to use 1 form of acceptable birth control
Who cannot join
- Donated blood within 56 days or donated plasma within 7 days prior to dosing
- History of significant multiple and/or severe allergies
- Recent history of respiratory tract infection
- History of cancer
- Body mass index <18 kg/m^2 or ≥40 kg/m^2
- History of major surgery or loss of 1 unit of blood
Show all 11Show fewer
- History of allergic reaction to sulfonamides
- Received medications within 14 days prior to randomization
- Significantly abnormal laboratory tests at Screening
- Current smoker, smoked within 5 years of Screening, or significant past smoking history
- History of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)
London, E1 2AX
About this study
Official title: A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection
The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).
- Conditions
- Acute Cough
- Being tested
- Gefapixant, Placebo
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 45 mg will be administered orally.
PlaceboDrug
Placebo tablet matching gefapixant will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Gefapixant 45 mg BID | Experimental | Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days. Receives: Drug: Gefapixant |
| Placebo BID | Placebo comparator | Participants will receive a matching placebo tablet BID for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awake Coughs Per Hour on Day 3
Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.
Measured: Day 3
Secondary outcomes (5)
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3
The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.
Measured: Baseline and Day 3
Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3
The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3.
Measured: Baseline and Day 3
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3
The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is 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-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3.
Measured: Baseline and Day 3
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 21 days
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start4 Jul 2018
- Primary completion31 Oct 2018
- Study completion19 Nov 2018
Why it stopped: The data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 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
- NCT03569033
- Sponsor's protocol ID
- 7264-013
- Other IDs
- MK-7264-013, 2017-000472-28, 2017
- Status last verified
- Nov 2019
- First submitted
- 14 Jun 2018
- Last updated
- 10 Dec 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
Publications
Smith JA, Kitt MM, Bell A, Noulin N, Tzontcheva A, Seng MM, Lu S. Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial. Pulm Ther. 2022 Sep;8(3):297-310. doi: 10.1007/s41030-022-00193-w. Epub 2022 Aug 15.
PubMed 35969360
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT03569033
- Acronym / sponsor ID
- 7264-013
- Conditions
- Acute Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 10 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gefapixant 45 mg BID | Experimental | Drug: GefapixantParticipants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days. |
| Placebo BID | Placebo comparator | Drug: PlaceboParticipants will receive a matching placebo tablet BID for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- In good general health
- Susceptible to human rhinovirus type 16 (HRV-16)
- Male or non-pregnant and non-breast feeding female
- If female of reproductive potential, agrees to use 1 form of acceptable birth control
Key exclusion criteria (11 listed)
- Donated blood within 56 days or donated plasma within 7 days prior to dosing
- History of significant multiple and/or severe allergies
- Recent history of respiratory tract infection
- History of cancer
- Body mass index <18 kg/m^2 or ≥40 kg/m^2
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 |
|---|---|---|
| GefapixantAlso: MK-7264Gefapixant 45 mg will be administered orally. | Drug | Gefapixant 45 mg BID |
| PlaceboPlacebo tablet matching gefapixant will be administered orally. | Drug | Placebo BID |
Primary outcome
Awake Coughs Per Hour on Day 3
Time frame: Day 3
Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.
5 secondary outcomes
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3
Time frame: Baseline and Day 3
Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3
Time frame: Baseline and Day 3
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3
Time frame: Baseline and Day 3
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
Time frame: Up to 21 days
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
Time frame: Up to Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35969360Smith JA, Kitt MM, Bell A, Noulin N, Tzontcheva A, Seng MM, Lu S. Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial. Pulm Ther. 2022 Sep;8(3):297-310. doi: 10.1007/s41030-022-00193-w. Epub 2022 Aug 15.
- 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
1 site 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 in people with Acute Cough, run by Merck Sharp & Dohme LLC at 1 site in United Kingdom.
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: stopped early, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 10 Dec 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?
Awake Coughs Per Hour on Day 3 (time frame: Day 3). 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 NCT03569033, 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 10 Dec 2019.