Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-304)

April 5, 2018 updated by: Glenmark Specialty S.A.

A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)

Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1176

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mission Viejo, California, United States
        • Investigational Site 406
      • Orange, California, United States
        • Investigational Site 414
      • San Diego, California, United States
        • Investigational Site 435
    • Colorado
      • Centennial, Colorado, United States
        • Investigational Site 420
      • Colorado Springs, Colorado, United States
        • Investigational Site 444
    • Florida
      • Aventura, Florida, United States
        • Investigational Site 428
      • Miami, Florida, United States
        • Investigational Site 412
    • Maryland
      • Bethesda, Maryland, United States
        • Investigational Site 436
    • Massachusetts
      • South Dartmouth, Massachusetts, United States
        • Investigational Site 432
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Investigational Site 426
      • Plymouth, Minnesota, United States
        • Investigational Site 403
    • Missouri
      • Columbia, Missouri, United States
        • Investigational Site 443
      • Rolla, Missouri, United States
        • Investigational Site 441
      • Saint Louis, Missouri, United States
        • Investigational Site 440
    • Nebraska
      • Bellevue, Nebraska, United States
        • Investigational Site 405
    • New Jersey
      • Skillman, New Jersey, United States
        • Investigational Site 434
    • New York
      • Rochester, New York, United States
        • Investigational Site 408
      • Rockville Centre, New York, United States
        • Investigational Site 418
    • North Carolina
      • High Point, North Carolina, United States
        • Investigational Site 402
      • Raleigh, North Carolina, United States
        • Investigational Site 427
    • Ohio
      • Cincinnati, Ohio, United States
        • Investigational Site 419
      • Cincinnati, Ohio, United States
        • United States 404
    • Oklahoma
      • Edmond, Oklahoma, United States
        • United States 407
      • Oklahoma City, Oklahoma, United States
        • Investigational Site 410
      • Tulsa, Oklahoma, United States
        • Investigational Site 424
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Investigational Site 411
    • South Carolina
      • Spartanburg, South Carolina, United States
        • Investigational Site 416
    • Texas
      • Austin, Texas, United States
        • Investigational Site 415
      • Austin, Texas, United States
        • Investigational Site 442
      • Boerne, Texas, United States
        • Investigational Site 417
      • Dallas, Texas, United States
        • Investigational Site 421
      • Dallas, Texas, United States
        • Investigational Site 430
      • El Paso, Texas, United States
        • Investigational Site 431
      • Kerrville, Texas, United States
        • Investigational Site 433
      • New Braunfels, Texas, United States
        • Investigational Site 422
      • San Antonio, Texas, United States
        • Investigational Site 401
      • San Antonio, Texas, United States
        • Investigational Site 413
      • San Antonio, Texas, United States
        • Investigational Site 425
      • San Antonio, Texas, United States
        • Investigational Site 437
      • Waco, Texas, United States
        • Investigational Site 400
      • Waco, Texas, United States
        • Investigational Site 409
    • Utah
      • Draper, Utah, United States
        • Investigational Site 423
    • Wisconsin
      • Greenfield, Wisconsin, United States
        • Investigational Site 439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and non-pregnant females who are 12 years of age and older.
  • Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
  • A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).

Exclusion Criteria:

  • Pregnant or lactating women.
  • History of anaphylaxis and/or other severe local reaction(s) to skin testing.
  • History of positive test for HIV, Hepatitis B or Hepatitis C infection.
  • Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
  • Subjects with an active pulmonary disorder or infection.
  • Subjects with posterior subcapsular cataracts or glaucoma
  • Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GSP 301 NS
Drug: GSP 301 NS
2 spray in each nostril twice daily for 14 days
Active Comparator: GOM-NS
Drug: GOM-NS
2 spray in each nostril twice daily for 14 days
Active Comparator: GMM-2 NS
Drug: GMM-2 NS
2 spray in each nostril twice daily for 14 days
Placebo Comparator: GSP 301 placebo NS
Drug: GSP 301 placebo NS
2 spray in each nostril twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
Time Frame: Baseline and day 14
The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).
Baseline and day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glenmark Specialty S.A.

Investigators

  • Study Director: Sudeesh Tantry, PhD, Glenmark Pharmaceuticals Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPL/CT/2015/004/III
  • Study Number: GSP 301-304 (Other Identifier: Glenmark Specialty S.A.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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