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Safety Study of Olopatadine Nasal Spray

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00578331
First received: December 19, 2007
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety Study of Olopatadine Nasal Spray

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 890
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Margaret Drake, Alcon
ClinicalTrials.gov Identifier: NCT00578331     History of Changes
Other Study ID Numbers: C-05-69
Study First Received: December 19, 2007
Results First Received: July 7, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 17, 2013