Status:
COMPLETED
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
Lead Sponsor:
Magna Pharmaceuticals, Inc.
Conditions:
Rhinitis, Allergic, Seasonal
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
No procedure will be performed until Informed Consent has been obtained. Inclusion and exclusion criteria will be verified. Subjects will be required to stop using oral nasal decongestants or first ge...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00932256
Start Date
October 1 2009
End Date
December 1 2010
Last Update
December 8 2010
Active Locations (1)
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1
Family Allergy and Asthma Research Institute
Louisville, Kentucky, United States, 40215