CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 679 enrolled
Drug / intervention
Mometasone furoate nasal spray +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03879772
NCT03879772Phase 3Completed
CompareCT.gov

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)

Organon and Co·interventional·Posted Mar 19, 2019·Updated Feb 9, 2022

In Brief

A Phase 3 clinical trial evaluating Mometasone furoate nasal spray, Beclomethasone dipropionate nasal spray, and 2 other interventions for Rhinitis, Allergic, Seasonal. Completed, enrolled 679 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Seasonal
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2019
Enrollment StartMar 12, 1996
Primary CompletionJul 1, 1996
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.3 years ago

Interventions

Mometasone furoate nasal spraydrug

intranasal administration

Beclomethasone dipropionate nasal spraydrug

intranasal administration

Placebo nasal spraydrug

intranasal administration

Chlorpheniramine maleate syrupdrug

oral administration