A Phase 2 interventional study of SCH 619734 and Placebo Dose 1 in Cough, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-27.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
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.
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 35 is below the median of 70 across 263 interventional studies indexed under Cough.
Browse Cough studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SCH 619734
Drug: Placebo Dose 1
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.
Also known as: Rolapitant
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.
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.
Time frame: At Days 7 and 63.
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.
Time frame: At Days 7 and 63.
No study locations are listed for this record.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC