Trial · NCT02318303
To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
NCT02318303, Phase 2, Completed, Glenmark Pharmaceuticals Ltd. India; results first posted 2017-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Study GSP 301 in Patients With Seasonal Allergic Rhinitis. Trials, record NCT02318303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02318303
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
- NCT number
- NCT02318303
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,111 participants, actual
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- GSP 301-1 NS (QD), GSP 301-2 NS (BID), GSP 301 Placebo NS, Olopatadine HCl-1 NS (QD), Olopatadine HCl-2 NS (BID), Mometasone Furoate-1 NS (QD), Mometasone Furoate-2 NS (BID)
- First posted
- 2014-12-17
- Last updated
- 2020-10-20
- Results first posted
- 2017-06-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in rTNSS From Baseline to End of Treatment | 14 days | Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows: * 0 = absent (no sign/symptom evident) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate \[i.e., causes interference with activities of daily living and/or sleeping\]) |
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 in rTNSS From Baseline to End of Treatment | 14 days | The full analysis set (FAS) included all randomized subjects who received at least one dose of randomized study medication 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 group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in rTNSS From Baseline to End of Treatment | GSP 301 Placebo | Baseline | 10.3 | Standard Deviation 1.18 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | GSP 301-1 NS (QD) | Baseline | 10.4 | Standard Deviation 1.24 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | Mometasone Furoate-1 NS (QD) | Baseline | 10.4 | Standard Deviation 1.30 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | Olopatadine HCl-1 NS (QD) | Baseline | 10.3 | Standard Deviation 1.26 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | GSP 301-2 NS (BID) | Baseline | 10.4 | Standard Deviation 1.19 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | Mometasone Furoate-2 NS (BID) | Baseline | 10.5 | Standard Deviation 1.13 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | Olopatadine HCl-2 NS (BID) | Baseline | 10.3 | Standard Deviation 1.24 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | GSP 301 Placebo | Change from Baseline to Visit 4 | -1.4 | Standard Deviation 2.00 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | GSP 301-1 NS (QD) | Change from Baseline to Visit 4 | -2.5 | Standard Deviation 2.52 | units on a scale |
| Change in rTNSS From Baseline to End of Treatment | Mometasone Furoate-1 NS (QD) | Change from Baseline to Visit 4 | -2.2 | Standard Deviation 2.68 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSP 301 Placebo NS | 159 | |
| Overall Study | STARTED | GSP 301-1 NS (QD) | 158 | |
| Overall Study | STARTED | Mometasone Furoate-1 NS (QD) | 160 | |
| Overall Study | STARTED | Olopatadine HCl-1 NS (QD) | 158 | |
| Overall Study | STARTED | GSP 301-2 NS (BID) | 157 | |
| Overall Study | STARTED | Mometasone Furoate-2 NS (BID) | 159 | |
| Overall Study | STARTED | Olopatadine HCl-2 NS (BID) | 160 | |
| Overall Study | COMPLETED | GSP 301 Placebo NS | 155 | |
| Overall Study | COMPLETED | GSP 301-1 NS (QD) | 155 | |
| Overall Study | COMPLETED | Mometasone Furoate-1 NS (QD) | 157 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events7
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 | Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | GSP 301 Placebo NS | 0 | 159 | 0 |
| serious | Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | GSP 301-1 NS (QD) | 1 | 158 | 2 |
| serious | Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | Mometasone Furoate-1 NS (QD) | 0 | 160 | 0 |
| serious | Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | Olopatadine HCl-1 NS (QD) | 0 | 158 | 0 |
| serious | Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | GSP 301-2 NS (BID) | 0 | 157 | 0 |
| serious | Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | Mometasone Furoate-2 NS (BID) | 0 | 159 | 0 |
| serious | Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | Olopatadine HCl-2 NS (BID) | 0 | 160 | 0 |
Source ClinicalTrials.gov
Adverse event totals21
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 301-1 NS (QD) | ||
| Total, all-cause mortality | Mometasone Furoate-1 NS (QD) | ||
| Total, all-cause mortality | Olopatadine HCl-1 NS (QD) | ||
| Total, all-cause mortality | GSP 301-2 NS (BID) | ||
| Total, all-cause mortality | Mometasone Furoate-2 NS (BID) | ||
| Total, all-cause mortality | Olopatadine HCl-2 NS (BID) | ||
| Total, other adverse events | GSP 301 Placebo NS | 0 | 159 |
| Total, other adverse events | GSP 301-1 NS (QD) | 0 | 158 |
| Total, other adverse events | Mometasone Furoate-1 NS (QD) | 0 | 160 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31734334 | 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/NCT02318303
GET https://conductscience.org/api/trials/v1/NCT02318303/flow?page=2