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NCT01222299 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
A Phase 1 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT01222299: Completed Phase 1 study, sponsored by Bausch & Lomb Incorporated.
NCT01222299 is a Phase 1 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222299, a Phase 1 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
Primary Outcome
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
Interventions
- DRUG bepotastine besilate nasal product - low dose
- DRUG bepotastine besilate nasal product - medium dose
- DRUG bepotastine besilate nasal product - high dose
- DRUG placebo comparator nasal product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
What the finished NCT01222299 record still lists
NCT01222299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 4 interventions - of which bepotastine besilate nasal product - low dose is the first listed.
NCT01222299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01222299 about?
NCT01222299 is a clinical study titled "Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber". The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
What is the current status of trial NCT01222299?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2010-05. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01222299?
The interventions under investigation include: bepotastine besilate nasal product - low dose (DRUG), bepotastine besilate nasal product - medium dose (DRUG), bepotastine besilate nasal product - high dose (DRUG), placebo comparator nasal product (DRUG).
Who is sponsoring clinical trial NCT01222299?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01222299's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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