Conditions: Rhinitis, Allergic, Perennial Rhinitis, Allergic, Nonseasonal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1482
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.). arm 2: Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.

Interventions: intervention 1: MK-8237 tablets intervention 2: Placebo tablets intervention 3: Rescue Medication: Self-Injectable Epinephrine intervention 4: Rescue Medication: Loratadine tablets intervention 5: Rescue Medication: Olopatadine ophthalmic drops intervention 6: Rescue Medication: Mometasone furoate nasal spray
Intervention descriptions: intervention 1: MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. intervention 2: Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. intervention 3: Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication. intervention 4: Loratadine tablet 10 mg administered orally as needed for rescue medication. intervention 5: Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication. intervention 6: Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.

Protocol document: