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SCH 900538

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Nov 2, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment265

FDA Designations

No designations recorded

Clinical trial landscape

SCH 900538 · 1 trial · 1 indication

Phase 2 1
NCT00673062Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)Seasonal Allergic Rhinitis
COMPLETED265 Analytics
PHASE2COMPLETED
Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)
Seasonal Allergic Rhinitis
NCT00673062265
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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 to 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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Frequently asked questions about SCH 900538

What is SCH 900538 used for?

SCH 900538 is an investigational small molecule being developed for the treatment of seasonal allergic rhinitis. It is designed to address symptoms of this condition, including nasal congestion. The drug is currently in Phase 2 clinical development and has not yet been approved by regulatory authorities.

Who makes SCH 900538?

SCH 900538 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for seasonal allergic rhinitis.

What phase is SCH 900538 in?

SCH 900538 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of seasonal allergic rhinitis, and its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is SCH 900538 in?

SCH 900538 has been studied in one completed Phase 2 clinical trial with the identifier NCT00673062. This trial, titled 'Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)', enrolled 265 participants and was a randomized, double-blind, placebo-controlled study.

Is SCH 900538 the same as any other drug?

SCH 900538 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Merck & Company, Inc. for the treatment of seasonal allergic rhinitis and is currently in Phase 2 clinical trials.