Clinical Trial Results:
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Summary
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EudraCT number |
2017-003856-22 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
24 Nov 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Feb 2018
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First version publication date |
02 Feb 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C-07-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00578929 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Alcon Research Ltd
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Sponsor organisation address |
6201 S. Freeway, Fort Worth, Texas, United States, 76134
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Public contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, dennis.wong@novartis.com
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Scientific contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, dennis.wong@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Nov 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Nov 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Nov 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study was to compare Olopatadine Hydrochloride (HCl) Nasal Spray 0.6% and Olopatadine HCl Nasal Spray Vehicle when given twice daily (BID) for the treatment of Seasonal Allergic Rhinitis (SAR) for a 2-week period.
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Protection of trial subjects |
Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Sep 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 1188
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Worldwide total number of subjects |
1188
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
1188
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 173 study centers in the United States. | ||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 2388 subjects were screened for possible study participation and given Olopatadine HCl Nasal Spray Vehicle as run-in treatment. Of these, 1200 subjects were screen failures and not enrolled into the study. The remaining 1188 subjects were enrolled into the randomized treatment period. This reporting group includes all treated subjects. | ||||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator, Subject | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Olo 0.6% 1 Spray | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Olopatadine HCl Nasal Spray 0.6%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Nasal use
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Dosage and administration details |
Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID
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Arm title
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Olo 0.6% 2 Sprays | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Olopatadine HCl Nasal Spray 0.6%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Nasal use
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Dosage and administration details |
Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID
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Arm title
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Veh 1 Spray | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Olopatadine HCl Nasal Spray Vehicle
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Nasal use
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Dosage and administration details |
Olopatadine HCl Nasal Spray Vehicle, 1 or 2 sprays per nostril BID
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Arm title
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Veh 2 sprays | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Olopatadine HCl Nasal Spray Vehicle
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Nasal use
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Dosage and administration details |
Olopatadine HCl Nasal Spray Vehicle, 1 or 2 sprays per nostril BID
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Baseline characteristics reporting groups
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Reporting group title |
Olo 0.6% 1 Spray
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Reporting group description |
Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Olo 0.6% 2 Sprays
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Reporting group description |
Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Veh 1 Spray
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Reporting group description |
Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Veh 2 sprays
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Reporting group description |
Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Olo 0.6% 1 Spray
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Reporting group description |
Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID | ||
Reporting group title |
Olo 0.6% 2 Sprays
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Reporting group description |
Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID | ||
Reporting group title |
Veh 1 Spray
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Reporting group description |
Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID | ||
Reporting group title |
Veh 2 sprays
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Reporting group description |
Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID | ||
Subject analysis set title |
Olo 0.6% 1 spray
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
This analysis population includes all subjects who received study medication and had at least 1 on-therapy visit (Intent-to-Treat (ITT) Analysis Set).
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Subject analysis set title |
Veh 1 spray
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Intent-to-Treat, with non-missing data at both visits and nonzero baseline data
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Subject analysis set title |
Olo 0.6% 2 sprays
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Intent-to-Treat, with non-missing data at both visits and nonzero baseline data
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Subject analysis set title |
Veh 2 sprays
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Intent-to-Treat, with non-missing data at both visits and nonzero baseline data
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Subject analysis set title |
Olo 0.6% 1 spray
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Intent-to-treat, with non-missing data at both visits and nonzero baseline data
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Subject analysis set title |
Veh 1 spray
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Intent-to-treat, with non-missing data at both visits and nonzero baseline data
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Subject analysis set title |
Olo 0.6% 2 sprays
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Intent-to-Treat, with non-missing data at both visits and nonzero baseline data
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Subject analysis set title |
Veh 2 sprays
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Intent-to-Treat, with non-missing data at both visits and nonzero baseline data
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End point title |
Percent Change from Baseline in rTNSS | ||||||||||||||||||||
End point description |
The rTNSS was defined as the average of the AM and PM reflective (how the subject felt for the last 12 hours) severity scores for the sum of assessments of runny nose, stuffy nose, itchy nose, and sneezing, averaged across the first 14 complete days of the randomized treatment phase. Symptoms were evaluated twice daily while on study therapy via a subject telephone diary and rated on a 4-unit scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A more negative change number indicates improvement, namely lessening of the symptom.
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End point type |
Primary
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End point timeframe |
Baseline, up through first 14 complete days of treatment
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Statistical analysis title |
Percent Change from Baseline in rTNSS | ||||||||||||||||||||
Comparison groups |
Olo 0.6% 2 sprays v Veh 2 sprays
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Number of subjects included in analysis |
586
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.012 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
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Statistical analysis title |
Percent Change from Baseline in rTNSS | ||||||||||||||||||||
Comparison groups |
Olo 0.6% 1 spray v Veh 1 spray
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Number of subjects included in analysis |
588
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.0007 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
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End point title |
Percent Change from Baseline in rTOSS | ||||||||||||||||||||
End point description |
The rTOSS was defined as the average of the AM and PM reflective severity scores for the sum of the assessments of ocular symptoms (itchy and watery eyes), averaged across 14 days. Symptoms were evaluated twice daily while on study therapy via a subject telephone diary and rated on a 4-unit scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A more negative change number indicates improvement, namely lessening of the symptom.
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End point type |
Secondary
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End point timeframe |
Baseline, up through first 14 complete days of treatment
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
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Adverse event reporting additional description |
Only total subjects affected by non-serious AEs that occur at >5% are reported.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
Olo 0.6% 1 Spray
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Reporting group description |
Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Olo 0.6% 2 Sprays
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Reporting group description |
Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Veh 1 Spray
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Reporting group description |
Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Veh 2 sprays
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Reporting group description |
Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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15 Jul 2008 |
Statistical analysis section revised to incorporate an analysis of covariance with randomization stratification factor and baseline TNSS as covariates, as instructed by Health Authority. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |