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Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)

Primary Purpose

Cough

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SCH 619734

Placebo Dose 1

About this trial

This is an interventional treatment trial for Cough

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects, 18 to <65 years old, with a history of a dry cough for >6 months.
By history, evaluation of gastroesophageal reflux disease was done and ruled out by a minimum of an 8-week trial of antacid therapy (with a proton-pump inhibitor [PPI] given twice daily) with no clinical response in cough.
By history, if there are clinical signs and symptoms of postnasal drip, these signs and symptoms will have been treated with a combination of an antihistamine and decongestant for a minimum of 8 weeks with no clinical response in cough.
By history, if there are clinical signs and symptoms of asthma, these signs and symptoms will have been treated with a combination of an inhaled steroid and a short-acting beta-agonist for a minimum of 8 weeks with no clinical response in cough.

Exclusion Criteria:

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, seizure disorders, and psychiatric disorders are to be excluded from participation in this study.
Subjects with asthma or chronic obstructive pulmonary disease who require chronic use of inhaled or systemic corticosteroids.
Subjects receiving concurrent prohibited medications unless they observe the washout period prior to the baseline visit. These medications would include opioid- and non-opioid-containing cough suppressants and potent CYP3A inhibitors, such as ritonavir, ketoconazole, and clarithromycin. Subjects receiving ACE inhibitors or MAOIs will be excluded from the study.
Subjects with a history of allergies to more than two classes of medications.
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.)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SCH 619734

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in cough reflex sensitivity as assessed by log10 C5 resulting from a capsaicin challenge. A capsaicin challenge will be performed on the first day of each treatment week (before dosing) and on the last day of each treatment week.

Secondary Outcome Measures

Change from baseline in hourly cough rate over 24 hours (using an automated cough counter). Baseline will be measured as the total number of coughs on Days -1 and 56 and compared with the total number of coughs on the last day of each treatment week.

Full Information

NCT ID

NCT00506545

First Posted

July 23, 2007

Last Updated

November 26, 2013

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00506545

Brief Title

Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)

Official Title

Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Idiopathic Cough

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH 619734 in subjects with chronic cough from an unknown cause. Subjects will be randomized to receive SCH 619734 or placebo for 7 days with 7 days' follow-up. After a 6 week washout period, subjects will be crossed over to the other treatment. The primary objective is to evaluate the effectiveness of SCH 619734 in reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that induces cough.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cough

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SCH 619734

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SCH 619734

Other Intervention Name(s)

Rolapitant

Intervention Description

SCH 619734 50-mg capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.

Intervention Type

Drug

Intervention Name(s)

Placebo Dose 1

Intervention Description

Matching placebo capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.

Primary Outcome Measure Information:

Title

Time Frame

At Days 7 and 63.

Secondary Outcome Measure Information:

Title

Time Frame

At Days 7 and 63.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects, 18 to <65 years old, with a history of a dry cough for >6 months. By history, evaluation of gastroesophageal reflux disease was done and ruled out by a minimum of an 8-week trial of antacid therapy (with a proton-pump inhibitor [PPI] given twice daily) with no clinical response in cough. By history, if there are clinical signs and symptoms of postnasal drip, these signs and symptoms will have been treated with a combination of an antihistamine and decongestant for a minimum of 8 weeks with no clinical response in cough. By history, if there are clinical signs and symptoms of asthma, these signs and symptoms will have been treated with a combination of an inhaled steroid and a short-acting beta-agonist for a minimum of 8 weeks with no clinical response in cough. Exclusion Criteria: 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, seizure disorders, and psychiatric disorders are to be excluded from participation in this study. Subjects with asthma or chronic obstructive pulmonary disease who require chronic use of inhaled or systemic corticosteroids. Subjects receiving concurrent prohibited medications unless they observe the washout period prior to the baseline visit. These medications would include opioid- and non-opioid-containing cough suppressants and potent CYP3A inhibitors, such as ritonavir, ketoconazole, and clarithromycin. Subjects receiving ACE inhibitors or MAOIs will be excluded from the study. Subjects with a history of allergies to more than two classes of medications. 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.)

12. IPD Sharing Statement

Learn more about this trial

Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)

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