Status:
COMPLETED
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
Lead Sponsor:
Magna Pharmaceuticals, Inc.
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two years. The st...
Eligibility Criteria
Inclusion
- Males and females of any ethnic group between 18 and 60 years of age.
- History of moderate to severe SAR for at least two years.
- 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.
- 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.
- Allergic hypersensitivity will be confirmed by the physician or well established patient medical history.
- Subject's compliance with requisite run-in period for each subject will be confirmed by investigator/designee.
Exclusion
- Pregnancy or lactation.
- Immunotherapy unless at a 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 IMP (STAHIST).
- Subject who is participating in any other clinical study.
- Subject who is unable to meet washout requirements.
- Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
- Subject with any family relationship to the sponsor, investigator, or staff of sponsor or investigator.
- A URI within 4 weeks of study inception.
- Subjects taking beta blockers or try-cyclic antidepressants. -
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01171664
Start Date
September 1 2010
End Date
January 1 2011
Last Update
March 26 2014
Active Locations (2)
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1
The South Bend Clinic
South Bend, Indiana, United States, 46617
2
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States, 40215