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To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo.
This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo containing no active pharmaceutical ingredients |
|
| STAHIST | Experimental | STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablet, one BID |
| |
| STAHIST |
| Measure | Description | Time Frame |
|---|---|---|
| Total Symptom Scores(TSS)reported and compared between the two study arms | TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip | Twice daily over the 2 week study period |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events--report and assess | Any/all adverse events will be recorded and scored, reported, evaluated, and results will be clinically and statistically compared between the placebo and active drug arms. | Continuous over the two week study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Pollard, MD | Family Allergy & Asthma Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The South Bend Clinic | South Bend | Indiana | 46617 | United States | ||
| Family Allergy & Asthma Research Institute |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2014 | |
| Reset | Jun 30, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2014 | Jun 30, 2014 |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Drug |
STAHIST in tablet form dosed one BID |
|
| Louisville |
| Kentucky |
| 40215 |
| United States |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |