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

NCT ID: NCT01171664

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-01-31

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 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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo containing no active pharmaceutical ingredients

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet, one BID

STAHIST

STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis

Group Type: EXPERIMENTAL

STAHIST

Intervention Type: DRUG

STAHIST in tablet form dosed one BID

Interventions

Placebo

Tablet, one BID

Intervention Type: DRUG

STAHIST

STAHIST in tablet form dosed one BID

Intervention Type: DRUG

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magna Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Pollard, MD

Role: PRINCIPAL_INVESTIGATOR

Family Allergy & Asthma Research Institute

Locations

The South Bend Clinic

South Bend, Indiana, United States

Family Allergy & Asthma Research Institute

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

105781-2

Identifier Type: -

Identifier Source: org_study_id