Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)

NCT03855189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2022-02-09

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Summary

The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Mometasone Furoate (MF)

Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks.

DRUG

Beclomethasone Dipropionate (BDP)

Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) \[336 mcg total dose per day\] for 4 weeks.

DRUG

Placebo

Placebo nasal spray administered for 4 weeks.

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
1993-08-23
Primary Completion
1993-10-08
Completion
1993-10-22

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Drugs

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 NCT03855189 on ClinicalTrials.gov