Skip to main content
OpenTrials
Completed

NCT Number: NCT01171664

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The South Bend Clinic, South Bend, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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. -

Treatment and study plan

Placebo

Drug

Tablet, one BID

STAHIST

Drug

STAHIST in tablet form dosed one BID

Primary outcomes

  1. Total Symptom Scores(TSS)reported and compared between the two study arms

    Time frame: Twice daily over the 2 week study period

    TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip

Secondary outcomes

  1. Adverse events--report and assess

    Time frame: Continuous over the two week study period

    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.

Sponsors and collaborators

Lead sponsor

Magna Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: STA-2

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 28, 2010
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.