CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01644617
NCT01644617Phase 2Completed
CompareCT.gov

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

ALK-Abelló A/S·interventional·Posted Jul 19, 2012·Updated Sep 15, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo, MK-8237 6 DU, and 1 other intervention for Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Nonseasonal. Completed, enrolled 124 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal
Countries--
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.0 years ago

Interventions

Placebodrug

Placebo rapidly dissolving tablets administered sublingually once daily

MK-8237 6 DUdrug

MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily

MK-8237 12 DUdrug

MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily