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Safety Study of Olopatadine Nasal Spray

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00578331
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : February 3, 2010
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Drug: Olopatadine 0.6% nasal spray Drug: Placebo Nasal Spray Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 890 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety Study of Olopatadine Nasal Spray
Study Start Date : December 2006
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Olopatadine 0.6% Nasal Spray
2 sprays each nostril twice daily
Drug: Olopatadine 0.6% nasal spray
2 sprays each nostril twice daily
Placebo Comparator: Placebo Nasal Spray
2 sprays each nostril twice daily
Drug: Placebo Nasal Spray
2 sprays each nostril twice daily



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Average Number of Days of Rescue Medication Taken [ Time Frame: Month 1 through Month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older

Exclusion Criteria:

  • Age 11 years and younger

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578331


Locations
United States, Texas
Waco
Waco, Texas, United States, 76712
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Margaret Drake Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00578331     History of Changes
Other Study ID Numbers: C-05-69
First Posted: December 21, 2007    Key Record Dates
Results First Posted: February 3, 2010
Last Update Posted: October 31, 2017
Last Verified: February 2010

Keywords provided by Alcon Research:
rhinitis
perennial allergic rhinitis
allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action