A Phase 3 interventional study of GSP 301 NS and GSP 301 Placebo NS pH 3.7 in Perennial Allergic Rhinitis, sponsored by Glenmark Specialty S.A.. Completed at 34 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Glenmark Specialty S.A. · Phase 3, Interventional, and Treatment
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Among 60 studies in Rhinitis, Allergic, Perennial with a site in United States — none open to participants now, 1 under way, 1 of them phase 3. Rhinitis, Allergic, Perennial · United States.
Among the 60 studies in Rhinitis, Allergic, Perennial with a site in United States, this one is the 10th largest by enrollment of the 57 interventional ones that give a count, is one of 2 that started in 2016, is one of 33 in phase 3, and was the 58th registered.
178 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 9 are open to participants now.
Browse Rhinitis, Allergic, Perennial studies →None of the 60 studies in Rhinitis, Allergic, Perennial with a site in United States is open now. The open studies under Rhinitis, Allergic, Perennial, anywhere →
Of the 3 Rhinitis, Allergic, Perennial studies recruiting now, none set no upper age limit and 3 stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
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60 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 6 · Phase 2 5 · Phase 3 33 · Phase 4 14
First in 2000; 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 601 is above the median of 135 across 157 interventional studies indexed under Rhinitis, Allergic, Perennial.
Median enrollment 301 across the 57 interventional studies, 824 across the 3 observational. Of the 58 that completed or were terminated, 37 (64%) have results posted.
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46 of 60 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 1 study filed under Rhinitis, Allergic, Perennial — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 60 studies in Rhinitis, Allergic, Perennial with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial 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.
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: GSP 301 Placebo NS pH 3.7
Drug: GSP 301 Placebo NS pH 7.0
FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
2 spray in each nostril twice daily for 52 weeks
2 spray in each nostril twice daily for 52 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Time frame: 52 weeks
| Milestone | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 |
|---|---|---|---|
| Started | 400 | 100 | 101 |
| Completed | 287 | 72 | 81 |
| Not completed | 113 | 28 | 20 |
| Withdrew: Adverse event | 13 | 2 | 3 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 24 | 8 | 4 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 40 | 7 | 4 |
| Withdrew: Non-compliance with study procedures | 5 | 0 | 0 |
| Withdrew: Non-compliance with study drug | 2 | 0 | 0 |
| Withdrew: Protocol deviation | 10 | 4 | 4 |
| Withdrew: Withdrawal by parent or legal guardian | 1 | 0 | 0 |
| Withdrew: Other | 16 | 7 | 5 |
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
| participants | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 |
|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs). | 203 | 41 | 54 |
Collected over The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSP 301 NS | 0/393 (0%) | 7/393 (1.8%) | 72/393 (18.3%) |
| GSP 301 Placebo NS pH 3.7 | 0/99 (0%) | 2/99 (2%) | 15/99 (15.2%) |
| GSP 301 Placebo NS pH 7.0 | 0/101 (0%) | 2/101 (2%) | 25/101 (24.8%) |
| Event | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 |
|---|---|---|---|
| AppendicitisInfections and infestations | 0/393 | 1/99 | 0/101 |
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 0/393 | 1/99 | 0/101 |
| CholelithiasisHepatobiliary disorders | 1/393 | 0/99 | 1/101 |
| NephrolithiasisRenal and urinary disorders | 0/393 | 0/99 | 1/101 |
| CellulitisInfections and infestations | 1/393 | 0/99 | 0/101 |
| PneumoniaInfections and infestations | 1/393 | 0/99 | 0/101 |
| Anaplastic astrocytomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/393 | 0/99 | 0/101 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/393 | 0/99 | 0/101 |
| Renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/393 | 0/99 | 0/101 |
| Triple negative breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/393 | 0/99 | 0/101 |
| Event | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 25/393 | 6/99 | 9/101 |
| NasopharyngitisInfections and infestations | 12/393 | 5/99 | 6/101 |
| HeadacheNervous system disorders | 16/393 | 3/99 | 5/101 |
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 11/393 | 2/99 | 5/101 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 18/393 | 2/99 | 2/101 |
Participants at the baseline measurement are less than that started because some subjects were not randomized or did not use the study drug on at least one occasion.
| Age, Continuous(years) | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 | Total |
|---|---|---|---|---|
| Mean | 40.4 ± 14.8 | 42.1 ± 15.4 | 41.2 ± 13.5 | 40.8 ± 14.7 |
| Sex: Female, Male(Participants) | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 | Total |
|---|---|---|---|---|
| Female | 269 | 68 | 68 | 405 |
| Male | 124 | 31 | 33 | 188 |
| Race (NIH/OMB)(Participants) | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 3 |
| Asian | 10 | 1 | 2 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 95 | 17 | 22 | 134 |
| White | 282 | 78 | 76 | 436 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 2 | 1 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Apr 2016, a primary completion of Jul 2017 and a completion of Jul 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2018, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. 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, Perennial →
Glenmark Specialty S.A.