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SCH 900538

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Other |Merck & Company, Inc.|Last Updated: Nov 2, 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 Trials1
Total Enrollment265
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00673062Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)PHASE2 COMPLETED 265 — — May 1, 2008Jul 1, 2008Nov 2, 2015 - —
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Study Endpoints
Primary Endpoints
Average change from baseline in nasal congestion scores over the first 4-hour observation period.
Over the first 4-hour observation period.
Secondary Endpoints
Average change from baseline in nasal congestion at each evaluation time point.
Over 12 hours.
Average change from baseline in total symptoms, total symptoms minus congestion, total nasal symptoms, total nasal symptoms minus congestion, total non-nasal symptoms, and individual symptoms scores.
Over the first 4 hour and 12-hour study periods.
Onset of action: defined as the first time point at which a sustained, statistically significant (P<=0.05) reduction relative to placebo in an efficacy variable (eg, nasal congestion) up to a pre-specified time point.
Over the first 4-hours and 12-hour study periods.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SCH 900538EXPERIMENTAL -
Encapsulated pseudoephedrineACTIVE_COMPARATOREncapsulated pseudoephedrine (2X30 mg immediate release tablets)
Placebo CapsulesPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SCH 900538DRUG(4X50mg Capsules)
PseudoephedrineDRUGEncapsulated pseudoephedrine (2X30 mg immediate release tablets)
Placebo CapsulesDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects must be 18 to 65 years of age, of either sex, and of any race. * Subjects must have a history of SAR due to ragweed for the last two consecutive ragweed seasons. * Subjects must be skin-test positive for the ragweed pollen allergen used in the Environmental Exposure U...

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