NCT01171664

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Magna Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Placebo	Tablet, one BID
DRUG	STAHIST	STAHIST in tablet form dosed one BID

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-10-01
• Completion: 2011-01-01
• First posted: 2010-07-28
• Last updated: 2014-03-26

Locations

2 sites across 1 country: United States