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NCT01277341 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
A Phase 2 study of Seasonal Allergic Rhinitis, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 601
- Enrollment target
- 1
- Study location
NCT01277341: Completed Phase 2 study of Seasonal Allergic Rhinitis, sponsored by Bausch & Lomb Incorporated.
NCT01277341 is a Phase 2 study of Seasonal Allergic Rhinitis that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 601 participants, roughly in line with the 631-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01277341, a Phase 2 study of Seasonal Allergic Rhinitis, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 601 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
Primary Outcome
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were each 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 minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were av
Conditions Studied
Interventions
- DRUG Placebo Nasal Spray
- DRUG Bepotastine Besilate Nasal Spray 2% Twice a day
- DRUG Bepotastine Besilate Nasal Spray 3% Twice a day
- DRUG Bepotastine Besilate Nasal Spray 4% Twice a day
Study Locations (1)
California
- ISTA Pharmaceuticals, Inc. - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT01277341 record still lists
NCT01277341 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 631-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target.
The record links to 1 condition, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo Nasal Spray is the first listed.
NCT01277341 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01277341 about?
NCT01277341 is a clinical study titled "Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis". This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
What is the current status of trial NCT01277341?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 601 participants. The study started on 2010-12. Estimated completion is 2011-05.
What conditions does trial NCT01277341 study?
This clinical trial studies the following conditions: Seasonal Allergic Rhinitis.
What interventions are being tested in trial NCT01277341?
The interventions under investigation include: Placebo Nasal Spray (DRUG), Bepotastine Besilate Nasal Spray 2% Twice a day (DRUG), Bepotastine Besilate Nasal Spray 3% Twice a day (DRUG), Bepotastine Besilate Nasal Spray 4% Twice a day (DRUG).
Who is sponsoring clinical trial NCT01277341?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01277341 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Seasonal Allergic Rhinitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01277341's enrollment target sits among peer trials
601 8th of 16 higher than 9 of 16 other Seasonal Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seasonal Allergic Rhinitis 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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