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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01171664
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Magna Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Placebo Drug: STAHIST Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo containing no active pharmaceutical ingredients
Drug: Placebo
Tablet, one BID

Experimental: STAHIST
STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis
STAHIST in tablet form dosed one BID

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01171664

United States, Indiana
The South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Kentucky
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States, 40215
Sponsors and Collaborators
Magna Pharmaceuticals, Inc.
Principal Investigator: Stephen J Pollard, MD Family Allergy & Asthma Research Institute

Responsible Party: Magna Pharmaceuticals, Inc. Identifier: NCT01171664     History of Changes
Other Study ID Numbers: 105781-2
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: September 2010

Keywords provided by Magna Pharmaceuticals, Inc.:
Phase 2

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases