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Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)

NCT01678807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2017-09-15

Study results available
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Summary

The purpose of this study is to evaluate the safety of two doses (6 Development Units \[DU\] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.

Conditions

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

Interventions

BIOLOGICAL

MK-8237 6 DU

BIOLOGICAL

MK-8237 12 DU

BIOLOGICAL

Placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-05-31
Completion
2013-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678807 on ClinicalTrials.gov