At a glance
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A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
In Brief
A Phase 3 clinical trial evaluating MK-8237 tablets, Placebo tablets, and 4 other interventions for Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Nonseasonal. Completed, enrolled 1,482 participants.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults. The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).
Study Details
Timeline
Interventions
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Loratadine tablet 10 mg administered orally as needed for rescue medication.
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.