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Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419)

NCT00779740 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-08-15

No results posted yet for this study

Summary

This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate \[MF\] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.

Conditions

  • Rhinitis, Allergic, Perennial

Interventions

DRUG

mometasone furoate

The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.

DRUG

mometasone furoate

The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-01
Primary Completion
2005-04-01
Completion
2005-04-01

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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 NCT00779740 on ClinicalTrials.gov