Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT01171664

Run by

Magna Pharmaceuticals, Inc.

People needed

100

Starts

2010-09-01

Expected to finish

2011-01-01

Last updated by the study team

2014-03-26

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 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.

You may not qualify if…

• 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. -

Where it is running

• The South Bend Clinic — South Bend, Indiana, United States
• Family Allergy & Asthma Research Institute — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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