Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
STAHIST IND 105781 Phase 1 Clinical Trial
Verified date | December 2010 |
Source | Magna Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase 1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements and blood levels of active ingredients over 12 hours; 2) To report subjective scores by subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse drug reactions and rate the severity of incidence.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 2010 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Males and females of any ethnic group between the ages of 18 and 60 years of age. - History of moderate to severe SAR for at least one year. - Subjects' symptoms will include the five symptoms ("S5") that are the focus of this study: - nasal congestion; - rhinorrhea; - nasal itching; - sneezing; - post nasal drip. - Prior to study subjects' good health will be confirmed by medical history and physical examination. - Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established medical history. Exclusion Criteria: - Pregnancy or lactation. - Immunotherapy unless at stable maintenance dose. - 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. - Alcohol dependence. - Use of any other investigational drug in the previous month. - Subjects presenting with asthma requiring corticosteroid treatment. - Subjects with multiple drug allergies. - Subjects known to have an idiosyncratic reaction to any of the ingredients in STAHIST. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Family Allergy and Asthma Research Institute | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Magna Pharmaceuticals, Inc. |
United States,
Moffitt EM. Symptomatic management of upper respiratory allergies. J Miss State Med Assoc. 1968 Apr;9(4):159-61. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours. | August 2009 | Yes | |
Secondary | To report any side effects or adverse drug reactions and rate the severity of incidence. | August 2009 | Yes |
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