- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00578331
Safety Study of Olopatadine Nasal Spray
September 29, 2017 updated by: Alcon Research
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
890
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Waco, Texas, United States, 76712
- Waco
-
-
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
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
Exclusion Criteria:
- Age 11 years and younger
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Olopatadine 0.6% Nasal Spray
2 sprays each nostril twice daily
|
2 sprays each nostril twice daily
|
Placebo Comparator: Placebo Nasal Spray
2 sprays each nostril twice daily
|
2 sprays each nostril twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
Time Frame: day 30
|
Mean Patient-Rated Relief Assessment at Day 30.
The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
|
day 30
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average Number of Days of Rescue Medication Taken
Time Frame: Month 1 through Month 12
|
Month 1 through Month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Margaret Drake, Alcon Research
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, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 21, 2007
Study Record Updates
Last Update Posted (Actual)
October 31, 2017
Last Update Submitted That Met QC Criteria
September 29, 2017
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Olopatadine Hydrochloride
Other Study ID Numbers
- C-05-69
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
-
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
-
UCB PharmaCompletedRhinitis | Allergic | Perennial
-
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 Olopatadine 0.6% nasal spray
-
Alcon ResearchCompletedPerennial Allergic RhinitisUnited States
-
Alcon ResearchCompletedAllergic RhinitisUnited States
-
DR. MALA KHANBangladesh Reference Institute of Chemical Measurements (BRICM)CompletedEfficacy, Self | Effect of Drug | Virus Infection, RNABangladesh
-
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
-
Alcon ResearchCompletedSeasonal Allergic RhinitisUnited States
-
Viiral Nordic ABCompleted
-
Oyster Point Pharma, Inc.CompletedDry Eye DiseaseUnited States