NCT Number: NCT00210015
A Study in Subjects With Perennial Allergic Rhinitis
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.
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Conditions
Study type
Interventional
Phase
Phase 2
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
total nasal symptom score
Secondary outcomes
-
average total nasal symptom scores over various timepoints average individual symptom scores
-
global assessment of perennial allergic rhinitis symptoms
-
instantaneous assessment of symptoms
-
change from baseline in quality of life assessments
-
physical and anterior nasal exams
-
laboratory tests
-
ECG
-
vital signs
-
adverse events
Sponsors and collaborators
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Registry information
Official study title
A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis
Important dates
- Study start
- 2002
- Primary completion
- 2003
- Study completion
- 2003
- First posted
- Sep 21, 2005
- Registry last updated
- Jan 25, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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