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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,482
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.
Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Number of Participants Who Experience At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 54 weeks
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 52 weeks
Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
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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.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)