- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210015
A Study in Subjects With Perennial Allergic Rhinitis
January 22, 2016 updated by: Merck Sharp & Dohme LLC
A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
630
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
total nasal symptom score
|
Secondary Outcome Measures
Outcome Measure |
---|
adverse events
|
vital signs
|
laboratory tests
|
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
|
ECG
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amy Schaberg, B.S.N.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Primary Completion (Actual)
April 1, 2003
Study Completion (Actual)
April 1, 2003
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
January 25, 2016
Last Update Submitted That Met QC Criteria
January 22, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Perennial Allergic Rhinitis
-
UCB PharmaCompletedRhinitis | Allergic | Perennial
-
United Allergy ServicesCompletedPerennial Allergic Rhinitis With Seasonal VariationUnited States
-
Eli Lilly and CompanyNot yet recruitingPerennial Allergic Rhinitis (PAR)United States
-
UCB PharmaCompletedRhinitis | Allergic | Perennial
-
Teva Branded Pharmaceutical Products R&D, Inc.United BioSource, LLCCompletedEffectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis (BALANCE)Perennial Allergic Rhinitis (PAR)United States
-
SanofiCompleted
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
Clinical Trials on INS37217 Nasal Spray
-
VistaGen Therapeutics, Inc.TerminatedSocial Anxiety DisorderUnited States
-
VistaGen Therapeutics, Inc.RecruitingSocial Anxiety DisorderUnited States
-
VistaGen Therapeutics, Inc.CompletedSocial Anxiety DisorderUnited States
-
University of ChicagoMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Withdrawn
-
Viiral Nordic ABCompleted
-
Oyster Point Pharma, Inc.CompletedDry Eye DiseaseUnited States
-
Imperial College LondonGlaxoSmithKlineCompleted
-
Sara EspinozaThe University of Texas Health Science Center, Houston; The University of Texas... and other collaboratorsCompletedObesity | Sedentary Lifestyle | Sarcopenia | Aging | Sarcopenic ObesityUnited States
-
P & B GroupMediAxe CROCompletedAllergic RhinitisFrance
-
P & B GroupMediAxe CROTerminatedSARS-CoV-2 InfectionFrance