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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

STAHIST

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Phase 2, SAR, STAHIST

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

The South Bend Clinic
Family Allergy & Asthma Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

STAHIST

Arm Description

Placebo containing no active pharmaceutical ingredients

STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01171664

First Posted

July 27, 2010

Last Updated

March 24, 2014

Sponsor

Magna Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01171664

Brief Title

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

Acronym

STA-2

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 Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Magna Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

Phase 2, SAR, STAHIST

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo containing no active pharmaceutical ingredients

Arm Title

STAHIST

Arm Type

Experimental

Arm Description

STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablet, one BID

Intervention Type

Drug

Intervention Name(s)

STAHIST

Intervention Description

STAHIST in tablet form dosed one BID

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Twice daily over the 2 week study period

Secondary Outcome Measure Information:

Title

Adverse events--report and assess

Description

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.

Time Frame

Continuous over the two week study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen J Pollard, MD

Organizational Affiliation

Family Allergy & Asthma Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The South Bend Clinic

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46617

Country

United States

Facility Name

Family Allergy & Asthma Research Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

12. IPD Sharing Statement

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

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