NCT01644617

A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)

A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects With House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of house dust mite (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that administration of MK-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (TNSS) determined during environmental exposure chamber (EEC) challenge.

Conditions

• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Nonseasonal

Interventions

Type	Name	Description
DRUG	Placebo	Placebo rapidly dissolving tablets administered sublingually once daily
DRUG	MK-8237 6 DU	MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily
DRUG	MK-8237 12 DU	MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-07-19
• Last updated: 2017-09-15
• Results posted: 2017-02-13