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Safety Study of Olopatadine Nasal Spray

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00578331
First Posted: December 21, 2007
Last Update Posted: October 31, 2017
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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 Intervention Phase
Perennial Allergic Rhinitis Drug: Olopatadine 0.6% nasal spray Drug: Placebo Nasal Spray Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

Enrollment: 890
Study Start Date: December 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00578331     History of Changes
Other Study ID Numbers: C-05-69
First Submitted: December 19, 2007
First Posted: December 21, 2007
Results First Submitted: July 7, 2009
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