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

Last updated: August 28, 2018
Sponsor: Glenmark Specialty S.A.
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT02631551
GPL/CT/2014/016/III
  • Ages > 12
  • All Genders

Study Summary

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the springallergy season (tree/grass pollen)

  3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 forthe AM assessment at the Screening Visit (Visit 1).

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women.

  2. Plans to travel outside the known pollen area for the investigative site for > 24hours during the last 7 days of run in period.

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

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

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

  6. Subjects with an active pulmonary disorder or infection.

  7. Subjects with posterior subcapsular cataracts or glaucoma

Study Design

Total Participants: 1180
Study Start date:
March 01, 2016
Estimated Completion Date:
July 31, 2016

Connect with a study center

  • Investigational Site 20

    Mission Viejo, California
    United States

    Site Not Available

  • Investigational Site 31

    San Diego, California
    United States

    Site Not Available

  • Investigational Site 29

    San Jose, California
    United States

    Site Not Available

  • Investigational Site 25

    Centennial, Colorado
    United States

    Site Not Available

  • Investigational Site 22

    Colorado Springs, Colorado
    United States

    Site Not Available

  • Investigational Site 10

    Jupiter, Florida
    United States

    Site Not Available

  • Investigational Site 30

    Miami, Florida
    United States

    Site Not Available

  • Investigational Site 37

    Marietta, Georgia
    United States

    Site Not Available

  • Investigational Site 15

    Stockbridge, Georgia
    United States

    Site Not Available

  • Investigational Site 23

    Stockbridge, Georgia
    United States

    Site Not Available

  • Investigational Site 11

    Louisville, Kentucky
    United States

    Site Not Available

  • Investigational Site 14

    Baltimore, Maryland
    United States

    Site Not Available

  • Investigational Site 33

    Wheaton, Maryland
    United States

    Site Not Available

  • Investigational Site 26

    Ypsilani, Michigan
    United States

    Site Not Available

  • Investigational Site 26

    Ypsilanti, Michigan
    United States

    Site Not Available

  • Investigational Site 19

    Minneapolis, Minnesota
    United States

    Site Not Available

  • Investigational Site 21

    Saint Louis, Missouri
    United States

    Site Not Available

  • Investigational Site 21

    St. Louis, Missouri
    United States

    Site Not Available

  • Investigational Site 16

    Bellevue, Nebraska
    United States

    Site Not Available

  • Investigational Site 12

    Skillman, New Jersey
    United States

    Site Not Available

  • Investigational Site 36

    Rochester, New York
    United States

    Site Not Available

  • Investigational Site 18

    Raleigh, North Carolina
    United States

    Site Not Available

  • Investigational Site 27

    Cincinatti, Ohio
    United States

    Site Not Available

  • Investigational Site 27

    Cincinnati, Ohio
    United States

    Site Not Available

  • Investigational Site 34

    Middleburg Heights, Ohio
    United States

    Site Not Available

  • Investigational Site 32

    Medford, Oregon
    United States

    Site Not Available

  • Investigational Site 35

    Portland, Oregon
    United States

    Site Not Available

  • Investigational Site 13

    Orangeburg, South Carolina
    United States

    Site Not Available

  • Investigational Site 17

    Spartanburg, South Carolina
    United States

    Site Not Available

  • Investigational Site 3

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 5

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 8

    Austin, Texas
    United States

    Site Not Available

  • Investigational Site 1

    Kerrville, Texas
    United States

    Site Not Available

  • Investigational Site 7

    New Braunfels, Texas
    United States

    Site Not Available

  • Investigational Site 2

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 4

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 6

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 9

    San Antonio, Texas
    United States

    Site Not Available

  • Investigational Site 28

    Waco, Texas
    United States

    Site Not Available

  • Investigational Site 24

    Draper, Utah
    United States

    Site Not Available

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