A Phase 3 interventional study of GSP 301 NS and GOM-NS in Seasonal Allergic Rhinitis (SAR), sponsored by Glenmark Specialty S.A.. Completed at 43 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.
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 8th largest by enrollment of the 101 interventional ones that give a count, is one of 2 that started in 2016, is one of 47 in phase 3, and was the 97th 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: 12 Years and older · 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. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,176 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.
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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 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Drug: GSP 301 NS
Drug: GOM-NS
Drug: GMM-2 NS
Drug: GSP 301 placebo NS
2 spray in each nostril twice daily for 14 days
2 spray in each nostril twice daily for 14 days
2 spray in each nostril twice daily for 14 days
2 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)
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).
Time frame: Baseline and day 14
| Milestone | GSP 301 Placebo NS | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS |
|---|---|---|---|---|
| Started | 294 | 294 | 294 | 294 |
| Completed | 284 | 289 | 287 | 287 |
| Not completed | 10 | 5 | 7 | 7 |
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).
| units on a scale | GSP 301 Placebo NS | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS |
|---|---|---|---|---|
| Baseline | 10.3 ± 1.2 | 10.1 ± 1.2 | 10.2 ± 1.3 | 10.2 ± 1.3 |
| Change from baseline to end of treatment | -2.9 ± 3.2 | -4.3 ± 3.1 | -3.6 ± 3.3 | -3.5 ± 3.5 |
Collected over The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSP 301 Placebo NS | — | 1/294 (0.3%) | 0/294 (0%) |
| GSP 301 NS | — | 0/294 (0%) | 0/294 (0%) |
| Olopatadine HCl NS | — | 2/294 (0.7%) | 0/294 (0%) |
| Mometasone Furoate NS | — | 1/293 (0.3%) | 0/293 (0%) |
| Event | GSP 301 Placebo NS | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS |
|---|---|---|---|---|
| Peritonsillar abscessInfections and infestations | 0/294 | 0/294 | 0/294 | 1/293 |
| OsteomyelitisInfections and infestations | 1/294 | 0/294 | 0/294 | 0/293 |
| DiverticulitisInfections and infestations | 0/294 | 0/294 | 1/294 | 0/293 |
| Ischaemic strokeNervous system disorders | 0/294 | 0/294 | 1/294 | 0/293 |
| SyncopeNervous system disorders | 1/294 | 0/294 | 0/294 | 0/293 |
| Large intestinal obstructionGastrointestinal disorders | 0/294 | 0/294 | 1/294 | 0/293 |
| Large intestine perforationGastrointestinal disorders | 0/294 | 0/294 | 1/294 | 0/293 |
| Foot fractureInjury, poisoning and procedural complications | 1/294 | 0/294 | 0/294 | 0/293 |
GSP 301 placebo NS: Due to repeated participation of same subject in 2 seasons, only 1 participation (fall period) was included; Mometasone furoate NS: 1 subject received wrong kit and was excluded; GSP 301 NS and olopatadine HCl NS: Due to coinciding participation of same subject at 2 different sites, both participation's were excluded.
| Age, Continuous(years) | GSP 301 Placebo NS | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | Total |
|---|---|---|---|---|---|
| Mean | 39.6 ± 14.93 | 39.9 ± 14.91 | 39.9 ± 14.62 | 39.2 ± 14.86 | 39.6 ± 14.81 |
| Sex: Female, Male(Participants) | GSP 301 Placebo NS | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | Total |
|---|---|---|---|---|---|
| Female | 176 | 202 | 189 | 170 | 737 |
| Male | 117 | 91 | 104 | 123 | 435 |
Ran from Aug 2016 to primary completion in Jan 2017, 5 months.
Results were first posted in Apr 2018, 1 year 3 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 5 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 Apr 2018. 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.