Trial Outcomes & Findings for Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age (NCT NCT00794144)

NCT ID: NCT00794144

Last Updated: 2010-03-04

Results Overview

The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 132 participants
• Primary outcome timeframe: Day 1 (Baseline) to Exit
• Results posted on: 2010-03-04

Participant Flow

Patients at medical clinics in the U.S. participated from October 03, 2008, through December 03, 2008.

negative allergic response; enrollment target met

Participant milestones

Measure	Olopatadine Hydrochloride Nasal Spray 0.6% Olopatadine Hydrochloride Nasal Spray 0.6%	Olopatadine Hydrochloride Nasal Spray Vehicle Olopatadine Hydrochloride Nasal Spray Vehicle
Overall Study STARTED	66	66
Overall Study COMPLETED	63	63
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age

Baseline characteristics by cohort

Measure	Olopatadine Hydrochloride Nasal Spray 0.6% n=66 Participants Olopatadine Hydrochloride Nasal Spray 0.6%	Olopatadine Hydrochloride Nasal Spray Vehicle n=66 Participants Olopatadine Hydrochloride Nasal Spray Vehicle	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	36 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	30 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline) to Exit

The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa

Outcome measures

Measure	Olopatadine Hydrochloride Nasal Spray 0.6% n=66 Participants Olopatadine Hydrochloride Nasal Spray 0.6%	Olopatadine Hydrochloride Nasal Spray Vehicle n=66 Participants Olopatadine Hydrochloride Nasal Spray Vehicle
Number of Participants With Anatomic Nasal Exam Abnormalities	3 Participants	2 Participants

Adverse Events

Olopatadine Hydrochloride Nasal Spray 0.6%

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Olopatadine Hydrochloride Nasal Spray Vehicle

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Olopatadine Hydrochloride Nasal Spray 0.6% n=66 participants at risk Olopatadine Hydrochloride Nasal Spray 0.6%	Olopatadine Hydrochloride Nasal Spray Vehicle n=66 participants at risk Olopatadine Hydrochloride Nasal Spray Vehicle
Respiratory, thoracic and mediastinal disorders Cough	9.1% 6/66 • Number of events 6 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited	10.6% 7/66 • Number of events 7 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited
General disorders Pyrexia	3.0% 2/66 • Number of events 2 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited	9.1% 6/66 • Number of events 7 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited
Gastrointestinal disorders Vomiting	4.5% 3/66 • Number of events 3 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited	6.1% 4/66 • Number of events 4 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited
Gastrointestinal disorders Diarrhoea	9.1% 6/66 • Number of events 6 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited	0.00% 0/66 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited
Respiratory, thoracic and mediastinal disorders Epistaxis	6.1% 4/66 • Number of events 4 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited	1.5% 1/66 • Number of events 1 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited
Injury, poisoning and procedural complications Injury	0.00% 0/66 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited	6.1% 4/66 • Number of events 4 • 2 Weeks (Day 1 to Exit) Adverse events volunteered and solicited

Additional Information

Alcon Clinical

Alcon Research Ltd

Phone: 888.451.3937; 817.568.6725

Email: medinfo@alconlabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER