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Safety and Efficacy of Bepotastine in the Treatment of Seasonal Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT01277341
Recruitment Status : Completed
First Posted : January 14, 2011
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Bepotastine besilate proprietary formulation Drug: Placebo comparator Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
Drug Information available for: Bepotastine

Arm Intervention/treatment
Experimental: Arm No. 1 Drug: Bepotastine besilate proprietary formulation
nasal spray

Experimental: Arm No. 2 Drug: Bepotastine besilate proprietary formulation
nasal spray

Experimental: Arm No. 3 Drug: Bepotastine besilate proprietary formulation
nasal spray

Placebo Comparator: Arm No. 4 Drug: Placebo comparator
nasal spray




Primary Outcome Measures :
  1. Total nasal symptom score [ Time Frame: Day -10 to Day 14 ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 12 years of age with a history of mountain cedar allergy

Exclusion Criteria:

  • No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277341


Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01277341     History of Changes
Other Study ID Numbers: S00082
First Posted: January 14, 2011    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases