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Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

NCT03855228 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 704

Last updated 2022-02-09

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.

Conditions

  • Rhinitis, Allergic

Interventions

DRUG

Mometasone furoate nasal spray (MFNS)

Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.

DRUG

Loratadine

Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.

DRUG

Placebo nasal spray

Daily dose of placebo administered as a nasal spray for 15 days.

DRUG

Placebo tablet

Daily dose of placebo administered as an oral tablet for 15 days.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

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
1995-03-01
Primary Completion
1995-08-07
Completion
1995-08-07

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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 NCT03855228 on ClinicalTrials.gov