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

December 19, 2007
February 23, 2010
December 2006
March 2008   (final data collection date for primary outcome measure)
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.
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire [ Time Frame: day 30 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00578331 on ClinicalTrials.gov Archive Site
Average Number of Days of Rescue Medication Taken [ Time Frame: Month 1 through Month 12 ] [ Designated as safety issue: No ]
average number of days to rescue mediciation was used and the mean response (average of visits 2 through the last scheduled or unscheduled visit) to the patient-rated relief assessment questionnaire. [ Time Frame: from baseline ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Study of Olopatadine Nasal Spray
Safety Study of Olopatadine Nasal Spray

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Perennial Allergic Rhinitis
  • Drug: Olopatadine 0.6% nasal spray
    2 sprays each nostril twice daily
  • Drug: Placebo Nasal Spray
    2 sprays each nostril twice daily
  • Experimental: Olopatadine 0.6% Nasal Spray
    2 sprays each nostril twice daily
    Intervention: Drug: Olopatadine 0.6% nasal spray
  • Placebo Comparator: Placebo Nasal Spray
    2 sprays each nostril twice daily
    Intervention: Drug: Placebo Nasal Spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
890
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Age 11 years and younger
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00578331
C-05-69
No
Margaret Drake, Alcon
Alcon Research
Not Provided
Study Director: Margaret Drake Alcon Research
Alcon Research
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP