Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects (STA-2)

Magna Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: STAHIST; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01171664

105781-2

Details and patient eligibility

About

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.

Full 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 study will take place in two sites, Louisville, KY and South Bend, IN. SAR symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females of any ethnic group between 18 and 60 years of age.
2. History of moderate to severe SAR for at least two years.
3. 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.
4. 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.
5. Allergic hypersensitivity will be confirmed by the physician or well established patient medical history.
6. Subject's compliance with requisite run-in period for each subject will be confirmed by investigator/designee.

Exclusion criteria

1. Pregnancy or lactation.
2. Immunotherapy unless at a stable maintenance dose.
3. 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.
4. Alcohol dependence.
5. Use of any other investigational drug in the previous month.
6. Subjects presenting with asthma requiring corticosteroid treatment.
7. Subjects with multiple drug allergies.
8. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP (STAHIST).
9. Subject who is participating in any other clinical study.
10. Subject who is unable to meet washout requirements.
11. Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
12. Subject with any family relationship to the sponsor, investigator, or staff of sponsor or investigator.
13. A URI within 4 weeks of study inception.
14. Subjects taking beta blockers or try-cyclic antidepressants. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo containing no active pharmaceutical ingredients

Treatment:

Drug: Placebo

STAHIST

Experimental group

Description:

STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis

Treatment:

Drug: STAHIST