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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01171664
Other study ID # 105781-2
Secondary ID
Status Completed
Phase Phase 2
First received July 27, 2010
Last updated March 24, 2014
Start date September 2010
Est. completion date January 2011

Study information

Verified date September 2010
Source Magna Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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. -

Study Design


Intervention

Drug:
Placebo
Tablet, one BID
STAHIST
STAHIST in tablet form dosed one BID

Locations

Country Name City State
United States Family Allergy & Asthma Research Institute Louisville Kentucky
United States The South Bend Clinic South Bend Indiana

Sponsors (1)

Lead Sponsor Collaborator
Magna Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Symptom Scores(TSS)reported and compared between the two study arms TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip Twice daily over the 2 week study period
Secondary Adverse events--report and assess 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. Continuous over the two week study period
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