CoughPhase 2NCT00230230
Comparison of SCH 486757 to Codeine and Placebo in Subjects With Persistent Postviral Cough (Study P03069AM2)(COMPLETED)
A Phase 2 study testing SCH 486757 in people with Cough, run by Merck Sharp & Dohme LLC.
Trial summary
This randomized, multicenter, parallel-group, double-blind, double-dummy, placebo- and active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with persistent cough resulting from a recent viral upper respiratory infection (URI). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cough
- What is being tested?
- SCH 486757
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be 18 to <65 years of age, of either sex, and of any race.
- At the prescreening visit (Visit 1), subjects must have a history of a persistent cough resulting from a recent viral URI.
- Subjects must be sufficiently clinically symptomatic at the screening visit (Visit 2).
- At the Baseline/Treatment Day 1 Visit (Visit 3), subjects must demonstrate an average cough severity score of at least 2 (moderate).
- Subjects must be in good health, free of any clinically significant disease, other than cough, that might interfere with the study schedule, evaluation, or interpretation of study-derived data.
- Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
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- Clinical laboratory tests (complete blood count, blood chemistries, and urinalysis) and electrocardiograms must be within normal limits or clinically acceptable to the investigator.
- Female subjects of childbearing potential must be using a medically accepted method of birth control.
- Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) (prescreening sample).
Who cannot join
- Subjects who are pregnant or nursing females.
- Subjects with a history of hypersensitivity to the study medications or to their excipients.
- Subjects who have used any study medication, including placebo, in an investigational protocol within 30 days prior to the prescreening visit (Visit 1).
- Subjects receiving concurrent prohibited medications, unless they observe the washout period prior to the screening and baseline visits (Visits 2 and 3).
- Subjects who are family members of the investigational study staff involved with this study.
- Subjects previously enrolled into this study (ie, signed informed consent).
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- Subjects with current evidence of clinically significant pulmonary (especially conditions that involve coughing), hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune, or other disease that precludes the subject's participation in the study. In particular, diabetics, uncontrolled hypertensives, and subjects with clinically significant cardiomyopathy, prostatic hypertrophy, glaucoma, and psychiatric disorders are to be excluded from participation in this study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study medication or interfere with the subject's ability to reliably complete the diary card.
- Subjects with asthma or chronic obstructive pulmonary disease who require chronic use of inhaled or systemic corticosteroids.
- Subjects with current or history of frequent clinically significant sinusitis or chronic purulent postnasal drip.
- Subjects with a history of allergies to more than two classes of medications.
- Subjects whose ability, in the opinion of the investigator or designee, to provide informed consent is compromised.
- Subjects with a history of noncompliance with medications or treatment protocols, or with a history of drug abuse.
- Current smokers, ex-smokers who stopped smoking in the previous 6 months, or subjects with a cumulative smoking history >10 pack-years will be excluded. (Pack-years is a way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked, eg, a 10 pack-year history is equal to smoking 1 pack per day for 10 years or 2 packs per day for 5 years, etc.)
- Subjects with current reflux disease.
About this study
Official title: SCH 486757 vs Codeine and Placebo in Subjects With Persistent Postviral Cough
This randomized, multicenter, parallel-group, double-blind, double-dummy, placebo- and active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with persistent cough resulting from a recent viral upper respiratory infection (URI). The primary objective is to assess the efficacy of SCH 486757 administered at a dose of 100 mg twice daily for 5 days in the reduction of cough severity score compared with placebo. The key secondary objective is to evaluate the reduction in the number of coughs with SCH 486757 compared with placebo. Because codeine is a widely used as a cough medication, it is included as a treatment arm in the study.
- Conditions
- Cough
- Being tested
- SCH 486757
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 486757Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230230
- Sponsor's protocol ID
- P03069
- Status last verified
- Sep 2015
- First submitted
- 22 Sep 2005
- Last updated
- 16 Sep 2015
- Results posted
- No
Publications
Woodcock A, McLeod RL, Sadeh J, Smith JA. The efficacy of a NOP1 agonist (SCH486757) in subacute cough. Lung. 2010 Jan;188 Suppl 1:S47-52. doi: 10.1007/s00408-009-9197-8.
PubMed 19937046
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCH 486757 vs Codeine and Placebo in Subjects With Persistent Postviral Cough
- ClinicalTrials.gov ID
- NCT00230230
- Acronym / sponsor ID
- P03069
- Conditions
- Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, multicenter, parallel-group, double-blind, double-dummy, placebo- and active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with persistent cough resulting from a recent viral upper respiratory infection (URI). The primary objective is to assess the efficacy of SCH 486757 administered at a dose of 100 mg twice daily for 5 days in the reduction of cough severity score compared with placebo. The key secondary objective is to evaluate the reduction in the number of coughs with SCH 486757 compared with placebo. Because codeine is a widely used as a cough medication, it is included as a treatment arm in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects must be 18 to <65 years of age, of either sex, and of any race.
- At the prescreening visit (Visit 1), subjects must have a history of a persistent cough resulting from a recent viral URI.
- Subjects must be sufficiently clinically symptomatic at the screening visit (Visit 2).
- At the Baseline/Treatment Day 1 Visit (Visit 3), subjects must demonstrate an average cough severity score of at least 2 (moderate).
- Subjects must be in good health, free of any clinically significant disease, other than cough, that might interfere with the study schedule, evaluation, or interpretation of study-derived data.
Key exclusion criteria (14 listed)
- Subjects who are pregnant or nursing females.
- Subjects with a history of hypersensitivity to the study medications or to their excipients.
- Subjects who have used any study medication, including placebo, in an investigational protocol within 30 days prior to the prescreening visit (Visit 1).
- Subjects receiving concurrent prohibited medications, unless they observe the washout period prior to the screening and baseline visits (Visits 2 and 3).
- Subjects who are family members of the investigational study staff involved with this study.
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 |
|---|---|---|
| SCH 486757 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- Results publication: PubMed 19937046Woodcock A, McLeod RL, Sadeh J, Smith JA. The efficacy of a NOP1 agonist (SCH486757) in subacute cough. Lung. 2010 Jan;188 Suppl 1:S47-52. doi: 10.1007/s00408-009-9197-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCH 486757 in people with Cough, run by Merck Sharp & Dohme LLC.
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 9 inclusion and 14 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 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00230230, 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 16 Sep 2015.