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

July 27, 2010
March 24, 2014
September 2010
October 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01171664 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: Placebo
    Tablet, one BID
  • Drug: STAHIST
    STAHIST in tablet form dosed one BID
  • Placebo Comparator: Placebo
    Placebo containing no active pharmaceutical ingredients
    Intervention: Drug: Placebo
  • Experimental: STAHIST
    STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis
    Intervention: Drug: STAHIST
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2011
October 2010   (final data collection date for primary outcome measure)

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. -
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01171664
105781-2
Yes
Magna Pharmaceuticals, Inc.
Magna Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Stephen J Pollard, MD Family Allergy & Asthma Research Institute
Magna Pharmaceuticals, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP