Trial · NCT02870205
Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
NCT02870205, Phase 3, Completed, Glenmark Specialty S.A.; results first posted 2018-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR). Trials, record NCT02870205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02870205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
- NCT number
- NCT02870205
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,176 participants, actual
- Lead sponsor
- Glenmark Specialty S.A.
- Conditions
- Seasonal Allergic Rhinitis (SAR)
- Interventions
- GSP 301 NS, GOM-NS, GMM-2 NS, GSP 301 placebo NS
- First posted
- 2016-08-17
- Last updated
- 2018-04-06
- Results first posted
- 2018-04-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | 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). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Baseline and day 14 | The FAS was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | GSP 301 Placebo NS | Baseline | 10.3 | Standard Deviation 1.2 | units on a scale |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | GSP 301 NS | Baseline | 10.1 | Standard Deviation 1.2 | units on a scale |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Olopatadine HCl NS | Baseline | 10.2 | Standard Deviation 1.3 | units on a scale |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Mometasone Furoate NS | Baseline | 10.2 | Standard Deviation 1.3 | units on a scale |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | GSP 301 Placebo NS | Change from baseline to end of treatment | -2.9 | Standard Deviation 3.2 | units on a scale |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | GSP 301 NS | Change from baseline to end of treatment | -4.3 | Standard Deviation 3.1 | units on a scale |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Olopatadine HCl NS | Change from baseline to end of treatment | -3.6 | Standard Deviation 3.3 | units on a scale |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Mometasone Furoate NS | Change from baseline to end of treatment | -3.5 | Standard Deviation 3.5 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSP 301 Placebo NS | 294 | |
| Overall Study | STARTED | GSP 301 NS | 294 | |
| Overall Study | STARTED | Olopatadine HCl NS | 294 | |
| Overall Study | STARTED | Mometasone Furoate NS | 294 | |
| Overall Study | COMPLETED | GSP 301 Placebo NS | 284 | |
| Overall Study | COMPLETED | GSP 301 NS | 289 | |
| Overall Study | COMPLETED | Olopatadine HCl NS | 287 | |
| Overall Study | COMPLETED | Mometasone Furoate NS | 287 | |
| Overall Study | NOT COMPLETED | GSP 301 Placebo NS | 10 | |
| Overall Study | NOT COMPLETED | GSP 301 NS | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Osteomyelitis | Infections and infestations | GSP 301 Placebo NS | 1 | 294 | 1 |
| serious | Osteomyelitis | Infections and infestations | GSP 301 NS | 0 | 294 | 0 |
| serious | Osteomyelitis | Infections and infestations | Olopatadine HCl NS | 0 | 294 | 0 |
| serious | Osteomyelitis | Infections and infestations | Mometasone Furoate NS | 0 | 293 | 0 |
| serious | Diverticulitis | Infections and infestations | GSP 301 Placebo NS | 0 | 294 | 0 |
| serious | Diverticulitis | Infections and infestations | GSP 301 NS | 0 | 294 | 0 |
| serious | Diverticulitis | Infections and infestations | Olopatadine HCl NS | 1 | 294 | 1 |
| serious | Diverticulitis | Infections and infestations | Mometasone Furoate NS | 0 | 293 | 0 |
| serious | Peritonsillar abscess | Infections and infestations | GSP 301 Placebo NS | 0 | 294 | 0 |
| serious | Peritonsillar abscess | Infections and infestations | GSP 301 NS | 0 | 294 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSP 301 Placebo NS | ||
| Total, all-cause mortality | GSP 301 NS | ||
| Total, all-cause mortality | Olopatadine HCl NS | ||
| Total, all-cause mortality | Mometasone Furoate NS | ||
| Total, other adverse events | GSP 301 Placebo NS | 0 | 294 |
| Total, other adverse events | GSP 301 NS | 0 | 294 |
| Total, other adverse events | Olopatadine HCl NS | 0 | 294 |
| Total, other adverse events | Mometasone Furoate NS | 0 | 293 |
| Total, serious adverse events | GSP 301 Placebo NS | 1 | 294 |
| Total, serious adverse events | GSP 301 NS | 0 | 294 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30910440 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02870205
GET https://conductscience.org/api/trials/v1/NCT02870205/events?page=2