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

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506545
• Other study ID #: P04888
• Secondary ID: SCH 619734
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2007
• Last updated: November 26, 2013
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: November 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		At Days 7 and 63.	No
Secondary	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.		At Days 7 and 63.	No