A Study in Subjects With Perennial Allergic Rhinitis

NCT ID: NCT00210015

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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INS37217 Nasal Spray

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Schaberg, B.S.N.

Role: STUDY_DIRECTOR

Other Identifiers

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07-105

Identifier Type: -

Identifier Source: org_study_id

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