Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
Completed · Phase 1
Conditions studied: Rhinitis, Allergic, Seasonal
In brief
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.
Key facts
- Study ID
- NCT00932256
- Run by
- Magna Pharmaceuticals, Inc.
- People needed
- 21
- Starts
- 2009-10-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2010-12-08
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Family Allergy and Asthma Research Institute — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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