Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

Last updated: February 12, 2020
Sponsor: Glenmark Specialty S.A.
Overall Status: Completed

Phase

3

Condition

Common Cold

Nasal Obstruction

Allergy

Treatment

N/A

Clinical Study ID

NCT02709538
GPL/CT/2014/018/III
  • Ages > 12
  • All Genders

Study Summary

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged ≥12 years and older inclusive of either sex.

  2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter atleast 3 mm greater than negative diluent control wheal) to at least 1 allergen knownto induce PAR. Documentation of a positive result within 12 months prior to theScreening Visit (Visit 1) is acceptable.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women.

  2. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

  3. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

  4. Documented evidence of acute or significant chronic sinusitis or chronic purulentpostnasal drip.

  5. Subjects with an active pulmonary disorder or infection.

  6. Subjects with posterior subcapsular cataracts or glaucoma

Study Design

Total Participants: 601
Study Start date:
April 01, 2016
Estimated Completion Date:
July 31, 2017

Connect with a study center

  • Investigational Site 2

    Hot Springs, Arkansas
    United States

    Site Not Available

  • Investigational Site 28

    Encinitas, California
    United States

    Site Not Available

  • Investigational Site 27

    San Diego, California
    United States

    Site Not Available

  • Investigational Site 29

    San Diego, California
    United States

    Site Not Available

  • Investigational Site 32

    Denver, Colorado
    United States

    Site Not Available

  • Investigational Site 26

    Aventura, Florida
    United States

    Site Not Available

  • Investigational Site 9

    Miami, Florida
    United States

    Site Not Available

  • Investigational Site 33

    Tallahassee, Florida
    United States

    Site Not Available

  • Investigational Site 11

    Stockbridge, Georgia
    United States

    Site Not Available

  • Investigational Site 4

    Louisville, Kentucky
    United States

    Site Not Available

  • Investigational Site 5

    Bethesda, Maryland
    United States

    Site Not Available

  • Investigational Site 15

    Saint Louis, Missouri
    United States

    Site Not Available

  • Investigational Site 15

    St. Louis, Missouri
    United States

    Site Not Available

  • Investigational Site 30

    Bellevue, Nebraska
    United States

    Site Not Available

  • Investigational Site 19

    Skillman, New Jersey
    United States

    Site Not Available

  • Investigational Site 18

    Corning, New York
    United States

    Site Not Available

  • Investigational Site 7

    High Point, North Carolina
    United States

    Site Not Available

  • Investigational Site 21

    Raleigh, North Carolina
    United States

    Site Not Available

  • Investigational Site 16

    Sylvania, Ohio
    United States

    Site Not Available

  • Investigational Site 22

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Investigational Site 13

    Spartanburg, South Carolina
    United States

    Site Not Available

  • Investigational Site 23

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 24

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 3

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 31

    Dallas, Texas
    United States

    Site Not Available

  • Investigational Site 34

    El Paso, Texas
    United States

    Site Not Available

  • Investigational Site 6

    Kerrville, Texas
    United States

    Site Not Available

  • Investigational Site 14

    New Braunfels, Texas
    United States

    Site Not Available

  • Investigational Site 1

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 10

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 12

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 17

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 20

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 25

    Waco, Texas
    United States

    Site Not Available

  • Investigational Site 8

    Waco, Texas
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.