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

Last updated: April 5, 2018
Sponsor: Glenmark Specialty S.A.
Overall Status: Completed

Phase

3

Condition

Nasal Obstruction

Allergy

Common Cold

Treatment

N/A

Clinical Study ID

NCT02870205
GPL/CT/2015/004/III
Study Number: GSP 301-304
  • Ages > 12
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

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 relevantseasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed ormountain cedar pollen)

  • A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AMassessment at the Screening Visit (Visit 1).

Exclusion

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 purulentpostnasal 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 24hours or longer during the last 7 days of the run-in period.

Study Design

Total Participants: 1176
Study Start date:
August 01, 2016
Estimated Completion Date:
January 31, 2017

Connect with a study center

  • Investigational Site 406

    Mission Viejo, California
    United States

    Site Not Available

  • Investigational Site 414

    Orange, California
    United States

    Site Not Available

  • Investigational Site 435

    San Diego, California
    United States

    Site Not Available

  • Investigational Site 420

    Centennial, Colorado
    United States

    Site Not Available

  • Investigational Site 444

    Colorado Springs, Colorado
    United States

    Site Not Available

  • Investigational Site 428

    Aventura, Florida
    United States

    Site Not Available

  • Investigational Site 412

    Miami, Florida
    United States

    Site Not Available

  • Investigational Site 436

    Bethesda, Maryland
    United States

    Site Not Available

  • Investigational Site 432

    Dartmouth, Massachusetts
    United States

    Site Not Available

  • Investigational Site 432

    South Dartmouth, Massachusetts
    United States

    Site Not Available

  • Investigational Site 426

    Minneapolis, Minnesota
    United States

    Site Not Available

  • Investigational Site 403

    Plymouth, Minnesota
    United States

    Site Not Available

  • Investigational Site 443

    Columbia, Missouri
    United States

    Site Not Available

  • Investigational Site 441

    Rolla, Missouri
    United States

    Site Not Available

  • Investigational Site 440

    Saint Louis, Missouri
    United States

    Site Not Available

  • Investigational Site 405

    Bellevue, Nebraska
    United States

    Site Not Available

  • Investigational Site 434

    Skillman, New Jersey
    United States

    Site Not Available

  • Investigational Site 408

    Rochester, New York
    United States

    Site Not Available

  • Investigational Site 418

    Rockville Centre, New York
    United States

    Site Not Available

  • Investigational Site 402

    High Point, North Carolina
    United States

    Site Not Available

  • Investigational Site 427

    Raleigh, North Carolina
    United States

    Site Not Available

  • Investigational Site 419

    Cincinnati, Ohio
    United States

    Site Not Available

  • United States 404

    Cincinnati, Ohio
    United States

    Site Not Available

  • United States 407

    Edmond, Oklahoma
    United States

    Site Not Available

  • Investigational Site 410

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Investigational Site 424

    Tulsa, Oklahoma
    United States

    Site Not Available

  • Investigational Site 411

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Investigational Site 416

    Spartanburg, South Carolina
    United States

    Site Not Available

  • Investigational Site 415

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 442

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 417

    Boerne, Texas
    United States

    Site Not Available

  • Investigational Site 421

    Dallas, Texas
    United States

    Site Not Available

  • Investigational Site 430

    Dallas, Texas
    United States

    Site Not Available

  • Investigational Site 431

    El Paso, Texas
    United States

    Site Not Available

  • Investigational Site 433

    Kerrville, Texas
    United States

    Site Not Available

  • Investigational Site 422

    New Braunfels, Texas
    United States

    Site Not Available

  • Investigational Site 401

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 413

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 425

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 437

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 400

    Waco, Texas
    United States

    Site Not Available

  • Investigational Site 409

    Waco, Texas
    United States

    Site Not Available

  • Investigational Site 423

    Draper, Utah
    United States

    Site Not Available

  • Investigational Site 439

    Greenfield, Wisconsin
    United States

    Site Not Available

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