Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-304)
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| ClinicalTrials.gov Identifier: NCT02870205 |
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Recruitment Status :
Completed
First Posted : August 17, 2016
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
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Sponsor:
Glenmark Specialty S.A.
Information provided by (Responsible Party):
Glenmark Specialty S.A.
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Brief 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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Seasonal Allergic Rhinitis (SAR) | Drug: GSP 301 NS Drug: GOM-NS Drug: GMM-2 NS Drug: GSP 301 placebo NS | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1176 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | August 2016 |
| Actual Primary Completion Date : | January 2017 |
| Actual Study Completion Date : | January 2017 |
| 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 |
Primary Outcome Measures :
- 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).
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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:
- 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.
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): NCT02870205
Locations
Show 43 study locations
Sponsors and Collaborators
Glenmark Specialty S.A.
Investigators
| Study Director: | Sudeesh Tantry, PhD | Glenmark Pharmaceuticals Ltd |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Glenmark Specialty S.A. |
| ClinicalTrials.gov Identifier: | NCT02870205 |
| Other Study ID Numbers: |
GPL/CT/2015/004/III Study Number: GSP 301-304 ( Other Identifier: Glenmark Specialty S.A. ) |
| First Posted: | August 17, 2016 Key Record Dates |
| Results First Posted: | April 6, 2018 |
| Last Update Posted: | April 6, 2018 |
| Last Verified: | April 2018 |
Additional relevant MeSH terms:
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Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Respiratory Tract Infections Infections Nose Diseases |
Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |