A Phase 3 interventional study of GSP 301 NS and Olopatadine HCl NS in Seasonal Allergic Rhinitis, sponsored by Glenmark Specialty S.A.. Completed at 37 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-09-25.
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 7th 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 96th 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 1,180 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 and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
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.
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.
Drug: GSP 301 NS
Drug: Olopatadine HCl NS
Drug: Mometasone furoate NS
Drug: GSP 301 Placebo NS
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
2 sprays in each nostril twice daily for 14 days
2 sprays in each nostril twice daily for 14 days
2 sprays in each nostril twice daily for 14 days
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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: 14 days
| Milestone | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | GSP 301 Placebo NS |
|---|---|---|---|---|
| Started | 302 | 297 | 294 | 287 |
| Completed | 289 | 278 | 283 | 276 |
| Not completed | 13 | 19 | 11 | 11 |
| Withdrew: Adverse event | 1 | 2 | 4 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 2 | 0 | 3 |
| Withdrew: Withdrawal by subject | 2 | 2 | 0 | 5 |
| Withdrew: Protocol deviation | 3 | 6 | 3 | 0 |
| Withdrew: Non-compliance with study procedures | 0 | 0 | 1 | 1 |
| Withdrew: Non-compliance with study drug | 1 | 0 | 0 | 0 |
| Withdrew: Other, specific reasons not collected | 5 | 7 | 2 | 2 |
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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 NS | Olopatadine HCl NS | Mometasone Furoate NS | GSP 301 Placebo NS |
|---|---|---|---|---|
| Baseline | 10.1 ± 1.2 | 10.3 ± 1.3 | 10.2 ± 1.2 | 10.2 ± 1.2 |
| Change from baseline to end of treatment | -3.6 ± 3.2 | -3.2 ± 3.1 | -3.5 ± 3.3 | -2.8 ± 3.2 |
Collected over The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSP 301 NS | 0/302 (0%) | 1/302 (0.3%) | 0/302 (0%) |
| Olopatadine HCl NS | 0/297 (0%) | 0/297 (0%) | 0/297 (0%) |
| Mometasone Furoate NS | 0/294 (0%) | 0/294 (0%) | 0/294 (0%) |
| GSP 301 Placebo NS | 0/287 (0%) | 0/287 (0%) | 0/287 (0%) |
| Event | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | GSP 301 Placebo NS |
|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/302 | 0/297 | 0/294 | 0/287 |
| Age, Continuous(years) | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | GSP 301 Placebo NS | Total |
|---|---|---|---|---|---|
| Mean | 39.5 ± 15.4 | 39.6 ± 14.9 | 38.7 ± 16.3 | 39.4 ± 14.8 | 39.3 ± 15.3 |
| Sex: Female, Male(Participants) | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | GSP 301 Placebo NS | Total |
|---|---|---|---|---|---|
| Female | 201 | 181 | 198 | 182 | 762 |
| Male | 101 | 116 | 96 | 105 | 418 |
| Race (NIH/OMB)(Participants) | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | GSP 301 Placebo NS | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 1 | 0 | 3 |
| Asian | 2 | 4 | 7 | 7 | 20 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 0 | 1 | 4 |
| Black or African American | 56 | 67 | 59 | 48 | 230 |
| White | 241 | 219 | 224 | 231 | 915 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 3 | 3 | 0 | 8 |
The record gives a start of Mar 2016, a primary completion of Jul 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2018, 2 years 1 month after primary completion. A results delay was requested in May 2017.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 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.