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

Seasonal Allergic Rhinitis Clinical Trial

— STA-2  

Official title:

A Bi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult Subjects With a History of Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171664
• Other study ID #: 105781-2
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2010
• Last updated: March 24, 2014
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2010
• Source: Magna Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Placebo
Tablet, one BID
• STAHIST
STAHIST in tablet form dosed one BID

Locations

Country	Name	City	State
United States	Family Allergy & Asthma Research Institute	Louisville	Kentucky
United States	The South Bend Clinic	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Magna Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Symptom Scores(TSS)reported and compared between the two study arms	TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip	Twice daily over the 2 week study period
Secondary	Adverse events--report and assess	Any/all adverse events will be recorded and scored, reported, evaluated, and results will be clinically and statistically compared between the placebo and active drug arms.	Continuous over the two week study period