NCT03879772

Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 679 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	Mometasone furoate nasal spray	intranasal administration
DRUG	Beclomethasone dipropionate nasal spray	intranasal administration
DRUG	Placebo nasal spray	intranasal administration
DRUG	Chlorpheniramine maleate syrup	oral administration

Timeline

• Start date: 1996-03-12
• Primary completion: 1996-07-01
• Completion: 1996-07-01
• First posted: 2019-03-19
• Last updated: 2022-02-09
• Results posted: 2019-08-12