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NCT00794144 · ClinicalTrials.gov registry record · Phase 2
Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
A Phase 2 study, sponsored by Alcon Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
NCT00794144: Completed Phase 2 study, sponsored by Alcon Research.
NCT00794144 is a Phase 2 study that has completed, run by Alcon Research. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00794144, a Phase 2 study, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
Primary Outcome
The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa
Interventions
- DRUG Olopatadine Hydrochloride Nasal Spray 0.6%
- DRUG Olopatadine Hydrochloride Nasal Spray Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00794144 record still lists
NCT00794144 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Olopatadine Hydrochloride Nasal Spray 0.6% is the first listed.
NCT00794144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00794144 about?
NCT00794144 is a clinical study titled "Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age". The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug...
What is the current status of trial NCT00794144?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2008-10.
What interventions are being tested in trial NCT00794144?
The interventions under investigation include: Olopatadine Hydrochloride Nasal Spray 0.6% (DRUG), Olopatadine Hydrochloride Nasal Spray Vehicle (DRUG).
Who is sponsoring clinical trial NCT00794144?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00794144's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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