Safety Study of Olopatadine Nasal Spray
This study has been completed.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00578331
First received: December 19, 2007
Last updated: February 23, 2010
Last verified: February 2010
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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 19, 2007 | ||||
| Last Updated Date | February 23, 2010 | ||||
| Start Date ICMJE | December 2006 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire [ Time Frame: day 30 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00578331 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Average Number of Days of Rescue Medication Taken [ Time Frame: Month 1 through Month 12 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety Study of Olopatadine Nasal Spray | ||||
| Official Title ICMJE | Safety Study of Olopatadine Nasal Spray | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Perennial Allergic Rhinitis | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 890 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00578331 | ||||
| Other Study ID Numbers ICMJE | C-05-69 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Margaret Drake, Alcon | ||||
| Study Sponsor ICMJE | Alcon Research | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Alcon Research | ||||
| Verification Date | February 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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