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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Magna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01171664
First received: July 27, 2010
Last updated: March 24, 2014
Last verified: September 2010
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
Drug: Placebo
Drug: STAHIST
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Magna Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Total Symptom Scores(TSS)reported and compared between the two study arms [ Time Frame: Twice daily over the 2 week study period ] [ Designated as safety issue: No ]
    TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip


Secondary Outcome Measures:
  • Adverse events--report and assess [ Time Frame: Continuous over the two week study period ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: STAHIST
STAHIST in tablet form dosed one BID

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171664

Locations
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.
Investigators
Principal Investigator: Stephen J Pollard, MD Family Allergy & Asthma Research Institute
  More Information

No publications provided

Responsible Party: Magna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01171664     History of Changes
Other Study ID Numbers: 105781-2
Study First Received: July 27, 2010
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Magna Pharmaceuticals, Inc.:
Phase 2
SAR
STAHIST

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

ClinicalTrials.gov processed this record on September 16, 2014