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

NCT ID: NCT00506545

Last Updated: 2013-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-10-31

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.

Conditions

Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SCH 619734

Group Type: EXPERIMENTAL

SCH 619734

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Dose 1

Intervention Type: DRUG

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.

Interventions

SCH 619734

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

Placebo Dose 1

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.

Intervention Type: DRUG

Other Intervention Names

Rolapitant

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Countries

United Kingdom

Other Identifiers

SCH 619734

Identifier Type: -

Identifier Source: secondary_id

P04888

Identifier Type: -

Identifier Source: org_study_id