Seasonal Allergic Rhinitis Clinical Trial
— STA-2Official title:
A Bi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult Subjects With a History of Seasonal Allergic Rhinitis
Verified date | September 2010 |
Source | Magna Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Males and females of any ethnic group between 18 and 60 years of age. 2. History of moderate to severe SAR for at least two years. 3. Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms that are th focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip. Subjects must have a TSS baseline score of at least 8 on the S5 Subject Diary. 4. Prior to study drug administration, subjects' good health will be confirmed by medical history and physical examination, including pregnancy test (urine dip) before study inception. 5. Allergic hypersensitivity will be confirmed by the physician or well established patient medical history. 6. Subject's compliance with requisite run-in period for each subject will be confirmed by investigator/designee. Exclusion Criteria: 1. Pregnancy or lactation. 2. Immunotherapy unless at a stable maintenance dose. 3. Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems. 4. Alcohol dependence. 5. Use of any other investigational drug in the previous month. 6. Subjects presenting with asthma requiring corticosteroid treatment. 7. Subjects with multiple drug allergies. 8. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP (STAHIST). 9. Subject who is participating in any other clinical study. 10. Subject who is unable to meet washout requirements. 11. Subject with clinically significant abnormal vital sign or laboratory value that precludes participation. 12. Subject with any family relationship to the sponsor, investigator, or staff of sponsor or investigator. 13. A URI within 4 weeks of study inception. 14. Subjects taking beta blockers or try-cyclic antidepressants. - |
Country | Name | City | State |
---|---|---|---|
United States | Family Allergy & Asthma Research Institute | Louisville | Kentucky |
United States | The South Bend Clinic | South Bend | Indiana |
Lead Sponsor | Collaborator |
---|---|
Magna Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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