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SCH 486757

Phase 2

Cough | Small molecule | Other |Merck & Company, Inc.|Last Updated: Sep 16, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00506987Study of the Efficacy and Safety of SCH 486757 in Subjects With Chronic Cough (Study P04887)PHASE2 COMPLETED 31 — — Jan 1, 2007Nov 1, 2007Aug 14, 2015 - —
NCT00230230Comparison of SCH 486757 to Codeine and Placebo in Subjects With Persistent Postviral Cough (Study P03069AM2)(COMPLETED)PHASE2 COMPLETED 91 — — Oct 1, 2005Apr 1, 2007Sep 16, 2015 - —
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Study Endpoints
Primary Endpoints
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.
After 2 weeks of treatment.
Secondary Endpoints
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.
After 2 weeks of treatment.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SCH 486757EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SCH 486757DRUGSCH 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
Placebo Dose 1DRUGMatching placebo capsules twice daily orally for 2 weeks followed by a 2 week washout period and 2 weeks of crossover treatment
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

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...

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