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| ID | Type | Description | Link |
|---|---|---|---|
| CTFZ07001 |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Allied Research International | INDUSTRY |
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Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bilastine 20mg once per day |
|
| 2 | Experimental | Bilastine 20mg twice per day |
|
| 3 | Experimental | Bilastine 10mg once per day |
|
| 4 | Experimental | Bilastine 10mg twice per day |
|
| 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilastine | Drug | Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in nasal symptom scores | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ocular symptom scores and quality of life scores; standard safety assessments | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ander Sologuren, MD | Faes Farma, S.A. | Study Director |
| Paul Ratner, MD | Sylvana Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Allergy and Asthma Clinic | Oklahoma City | Oklahoma | 73104 | United States | ||
| MetaClin Research Inc. |
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| Placebo | Drug | Placebo tablets twice daily for 14 days |
|
| Austin |
| Texas |
| 78704 |
| United States |
| Austin Clinical Research | Austin | Texas | 78750 | United States |
| Lovelace Scientific Resources | Austin | Texas | 78759 | United States |
| Kerrville Research Associates | Kerrville | Texas | 78028-6071 | United States |
| Biogenics Research Institute | San Antonio | Texas | 78229 | United States |
| DGD Research | San Antonio | Texas | 78229 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Southwest Allergy and Asthma Centre | San Antonio | Texas | 78229 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Live Oak Allergy and Asthma | San Antonio | Texas | 78233 | United States |
| Allergy & Asthma Care of Waco | Waco | Texas | 76708 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D003233 | Conjunctivitis, Allergic |
| D006967 | Hypersensitivity |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C445659 | bilastine |
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