A Phase 3 interventional study of GSP 301 NS and GSP 301 Placebo NS in Seasonal Allergic Rhinitis (SAR), sponsored by Glenmark Specialty S.A.. Completed at 32 sites in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Glenmark Specialty S.A. · Phase 3, Interventional, and Treatment
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Among 107 studies in Rhinitis, Allergic, Seasonal with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Rhinitis, Allergic, Seasonal · United States.
Among the 107 studies in Rhinitis, Allergic, Seasonal with a site in United States, this one is the 51st largest by enrollment of the 101 interventional ones that give a count, is one of 3 that started in 2018, is one of 47 in phase 3, and was the 100th registered.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
Browse Rhinitis, Allergic, Seasonal studies →1 of the 107 studies in Rhinitis, Allergic, Seasonal with a site in United States is open now. Recruiting first, the newest first:
Polyrizon Ltd. · Sites in United States
Ages 18–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Rhinitis, Allergic, Seasonal studies recruiting now, 2 (12%) set no upper age limit and 15 (88%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.
This study: 6 Years to 11 Years · all sexes · no healthy volunteers.
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107 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 24 · Phase 3 48 · Phase 4 18
First in 2001; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 446 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Median enrollment 446 across the 101 interventional studies, 92 across the 5 observational. Of the 100 that completed or were terminated, 56 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
86 of 107 have an industry lead sponsor. The 10 most frequent:
Glenmark Specialty S.A. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Glenmark Specialty S.A. has 3 studies filed under Rhinitis, Allergic, Seasonal — fewer than ten, so there is no comparison to draw.
1 of the studies in Rhinitis, Allergic, Seasonal with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07588672Polyrizon Ltd.Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis | 2027-07-15 |
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Among the 107 studies in Rhinitis, Allergic, Seasonal with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS
Drug: GSP 301 NS
GSP 301 Placebo nasal spray
Drug: GSP 301 Placebo NS
1 spray in each nostril twice daily for 14 days
1 spray in each nostril twice daily for 14 days
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period
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). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.
Time frame: Baseline and day 14
Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.
The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous (ie, an evaluation of the symptom severity just before taking study medication \[within 10 minutes\]) of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the iTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the iTNSS is summed. The total score of the iTNSS ranged from 0 to 12.
Time frame: Baseline and day 14
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)
The PRQLQ is a validated, disease-specific, quality-of-life (QOL) questionnaire developed to measure the physical, emotional, and social impairments that are experienced by children (aged ≥6 to \<12 years) with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation and other symptoms). Subjects recall how they have been during the previous week and respond to each question on a 7-point scale with scores ranging from 6 (extremely bothered), 5 (very bothered), 4 (quite bothered), 3 (somewhat bothered), 2 (bothered a bit), 1 (hardly bothered at all), 0 (not bothered). The Overall PRQLQ score is the mean of all 23 subject-reported responses. The Overall PRQLQ score range from 0 to 6 where 0 represents no impairment and 6 represents maximum impairment.
Time frame: Baseline and day 15
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.
The Total Ocular Symptom Score (TOSS) will be calculated using the 3 eye-related non-nasal symptoms: itching/burning eyes, tearing/watering eyes, and redness of eyes. The subject will assess and report his/her non-nasal symptoms twice (AM and PM assessments). Scores ranged from 0 (No sign/symptom evident), 1 (Sign/symptom clearly present but minimal awareness; easily tolerated), 2 (Definite awareness of sign/symptom that is bothersome but tolerable) and 3 (Sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The Total Ocular Symptom Score (TOSS) ranged from 0 to 9.
Time frame: Baseline and day 14
| Milestone | GSP 301 NS | Placebo NS |
|---|---|---|
| Started | 225 | 221 |
| Completed | 215 | 216 |
| Not completed | 10 | 5 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Investigator/sponsor decision | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Use of prohibited medication by subject | 1 | 0 |
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). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 8.83 ± 1.41 | 8.84 ± 1.66 |
| Mean Change from baseline to end of treatment | -2.2 ± 0.17 | -1.6 ± 0.18 |
The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous (ie, an evaluation of the symptom severity just before taking study medication \[within 10 minutes\]) of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the iTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the iTNSS is summed. The total score of the iTNSS ranged from 0 to 12.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 7.89 ± 1.93 | 7.82 ± 2.04 |
| Mean Change from baseline to end of treatment | -1.8 ± 0.17 | -1.1 ± 0.17 |
The PRQLQ is a validated, disease-specific, quality-of-life (QOL) questionnaire developed to measure the physical, emotional, and social impairments that are experienced by children (aged ≥6 to \<12 years) with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation and other symptoms). Subjects recall how they have been during the previous week and respond to each question on a 7-point scale with scores ranging from 6 (extremely bothered), 5 (very bothered), 4 (quite bothered), 3 (somewhat bothered), 2 (bothered a bit), 1 (hardly bothered at all), 0 (not bothered). The Overall PRQLQ score is the mean of all 23 subject-reported responses. The Overall PRQLQ score range from 0 to 6 where 0 represents no impairment and 6 represents maximum impairment.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 2.51 ± 1.078 | 2.42 ± 1.001 |
| Mean Change from baseline to end of treatment | -0.8 ± 0.08 | -0.5 ± 0.08 |
The Total Ocular Symptom Score (TOSS) will be calculated using the 3 eye-related non-nasal symptoms: itching/burning eyes, tearing/watering eyes, and redness of eyes. The subject will assess and report his/her non-nasal symptoms twice (AM and PM assessments). Scores ranged from 0 (No sign/symptom evident), 1 (Sign/symptom clearly present but minimal awareness; easily tolerated), 2 (Definite awareness of sign/symptom that is bothersome but tolerable) and 3 (Sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The Total Ocular Symptom Score (TOSS) ranged from 0 to 9.
| units on a scale | GSP 301 NS | Placebo NS |
|---|---|---|
| Baseline | 3.84 ± 2.45 | 3.59 ± 2.52 |
| Mean Change from baseline to end of treatment | -0.8 ± 0.14 | -0.6 ± 0.13 |
Collected over AEs and SAEs were collected from the time of signing the informed consent form (ICF) until the follow up contact which was approximately 22 days and up to 27 days with 7 to 10 days of a placebo run-in period and 14 days of treatment period, with allowable window periods for the study visits.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSP 301 NS | 0/225 (0%) | 0/225 (0%) | 0/225 (0%) |
| Placebo NS | 0/221 (0%) | 1/221 (0.5%) | 0/221 (0%) |
| Event | GSP 301 NS | Placebo NS |
|---|---|---|
| Meningitis viralInfections and infestations | 0/225 | 1/221 |
| Age, Continuous(years) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| Mean | 8.7 ± 1.6 | 8.6 ± 1.7 | 8.7 ± 1.7 |
| Age, Customized(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| 6 - < 9 | 100 | 99 | 199 |
| 9 - < 12 | 125 | 122 | 247 |
| Sex: Female, Male(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| Female | 99 | 109 | 208 |
| Male | 126 | 112 | 238 |
| Ethnicity (NIH/OMB)(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| Hispanic or Latino | 67 | 85 | 152 |
| Not Hispanic or Latino | 158 | 135 | 293 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | GSP 301 NS | Placebo NS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 5 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 46 | 44 | 90 |
| White | 168 | 169 | 337 |
| More than one race | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Nov 2018, 7 months.
Results were first posted in Oct 2019, 10 months after primary completion.
Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, Seasonal, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's 7 months is above that.
Counting every sponsor, half of 37 studies reached it within 4 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSP 301
Rhinitis, Allergic, Seasonal →
Glenmark Specialty S.A.