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NCT01753739 · ClinicalTrials.gov registry record · Phase 2

Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)

A Phase 2 study, sponsored by Bausch & Lomb Incorporated.

Completed
Registry status
Phase 2
Development phase
617
Enrollment target

NCT01753739: Completed Phase 2 study, sponsored by Bausch & Lomb Incorporated.

NCT01753739 is a Phase 2 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 617 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (364% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01753739, a Phase 2 study, has completed, sponsored by Bausch & Lomb Incorporated.

COMPLETED
Registry status
Phase 2
Development phase
617 participants
Enrollment target

Study Summary

This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.

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

Interventions

  • DRUG Placebo
  • DRUG Bepotastine besilate

Trial Details

FieldValue
Enrollment Target 617 participants
Start Date 2013-01
Est. Completion 2013-05
Phase Phase 2
Bausch & Lomb Incorporated

174 total trials

What the finished NCT01753739 record still lists

NCT01753739 is an interventional study that assigns participants to a tested intervention. The registered 617 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (364% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01753739 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01753739 about?

NCT01753739 is a clinical study titled "Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)". This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen f...

What is the current status of trial NCT01753739?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 617 participants. The study started on 2013-01. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01753739?

The interventions under investigation include: Placebo (DRUG), Bepotastine besilate (DRUG).

Who is sponsoring clinical trial NCT01753739?

This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01753739's enrollment target sits among peer trials

617 53rd of 2000 higher than 1,948 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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Source: ClinicalTrials.gov NCT01753739, the US trial registry maintained by the National Library of Medicine. NCT01753739 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.