A Phase 2 interventional study of SCH 486757 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 2015-08-14.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH 486757 in subjects with chronic cough. Subjects will be randomized to receive SCH 486757 or placebo for 14 days. After a 2-week washout period, subjects will be crossed over to the other treatment. The primary objective is to evaluate the effectiveness of SCH 486757 in reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that induces cough.
356 studies on the registry are indexed under Cough; 72 are open to participants now.
This study's enrollment of 31 is below the median of 71 across 270 interventional studies indexed under Cough.
Browse Cough studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,163 studies on the registry; 134 are open to participants now.
Of its 498 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
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Exclusion Criteria:
Drug: SCH 486757
Drug: Placebo Dose 1
SCH 486757 2 x 50-mg capsule twice daily orally for 2 weeks followed by a 2-week washout period and 2 weeks of crossover treatment
Matching placebo capsules twice daily orally for 2 weeks followed by a 2 week washout period and 2 weeks of crossover treatment
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 (before dosing) and on the last day of each 2 week treatment period.
Time frame: After 2 weeks of treatment.
Change from baseline in hourly cough rate over 24 hours (using an automated cough counter). Baseline will be measured as the total no. of coughs on Day 1 of each treatment period and compared with the same value on the last day of each treatment period.
Time frame: After 2 weeks of treatment.
No study locations are listed for this record.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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