A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis

Merck Sharp & Dohme LLC0 sites630 target enrollmentDecember 2002

ConditionsPerennial Allergic Rhinitis

DrugsINS37217 Nasal Spray

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Perennial Allergic Rhinitis
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 630
Primary Endpoint: total nasal symptom score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

April 2003

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
•Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
•Have not started or had a change in immunotherapy regimen.

Exclusion Criteria

•Have a physical obstruction in the nose.
•Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
•Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
•Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
•Have asthma of sufficient severity to require use of excluded medications.
•Have taken any medications excluded as listed in the protocol.
•Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
•Are a current smoker, recent smoker or past smoker as defined in the protocol.

Outcomes

Primary Outcomes

total nasal symptom score

Secondary Outcomes

laboratory tests
global assessment of perennial allergic rhinitis symptoms
physical and anterior nasal exams
vital signs
adverse events
change from baseline in quality of life assessments
instantaneous assessment of symptoms
ECG
average total nasal symptom scores over various timepoints average individual symptom scores