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Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

NCT01700192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1482

Last updated 2017-09-15

Study results available
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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).

Conditions

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

Interventions

BIOLOGICAL

MK-8237 tablets

MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.

BIOLOGICAL

Placebo tablets

Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.

DRUG

Rescue Medication: Self-Injectable Epinephrine

Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.

DRUG

Rescue Medication: Loratadine tablets

Loratadine tablet 10 mg administered orally as needed for rescue medication.

DRUG

Rescue Medication: Olopatadine ophthalmic drops

Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.

DRUG

Rescue Medication: Mometasone furoate nasal spray

Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

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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 NCT01700192 on ClinicalTrials.gov