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Trial of STAHIST in Seasonal Allergic Rhinitis

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

STAHIST

Placebo

About this trial

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

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and females of any ethnic group between 12 and 60 years of age.
History of moderate to severe Seasonal Allergic Rhinitis (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 ("S5") that are the focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal drip. Subjects must have an average 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 & 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 the individual will be confirmed by the investigator/designee.

Exclusion Criteria:

Pregnancy or lactation.
Immunotherapy unless at 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.
Subject who has used any investigational drugs within 30 days of the screening visit.
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.
Subjects with any family relationship to Sponsor, Investigator, or staff of Sponsor or Investigator.
A URI within 4 weeks of study inception.
Subjects taking beta blockers or tri-cyclic antidepressants will not be allowed to participate in the study.

Sites / Locations

Clinical Research Atlanta
The South Bend Clinic
Family Allergy and Asthma Institute
Family Allergy and Asthma
New Horizons Clinical Research
National Allergy, Asthma & Urticaria Centers of Charleston, PA
Pharmaceutical Research and Consulting, Inc
Central Texas Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

STAHIST Investigational Medical Product

Placebo

Arm Description

STAHIST Tablet, dosed one tablet BID

Placebo tablet, identical appearance to IMP, dosed one tablet BID

Outcomes

Primary Outcome Measures

Total Symptom Scores (TSS)

To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period.

Secondary Outcome Measures

Adverse Events (AEs) Assessment

B) Report any side effects or adverse drug reactions and rate the severity of any incident.

Full Information

NCT ID

NCT01293201

First Posted

February 8, 2011

Last Updated

August 31, 2011

Sponsor

Magna Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01293201

Brief Title

Trial of STAHIST in Seasonal Allergic Rhinitis

Official Title

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult and Adolescent Subjects With a History of Seasonal Allergic Rhinitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Magna Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B) Report any side effects or adverse drug reactions and rate the severity of any incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip symptom scores (PND-S) between the two study arms.

Detailed Description

Phase 3 clinical trial will be conducted in conformance with Good Clinical Practices and is a multi-center, double-blind, randomized, placebo-controlled, parallel-group study evaluating the safety and efficacy of STAHIST (IMP) in 300 adult and adolescent subjects 12-60 years of age, of either sex or any race with a minimum 2-year history of seasonal allergic rhinitis (SAR) and a baseline minimum total symptom score (TSS) of not less than 8 on the S5 Subject Diary. Subjects will be treated twice daily with IMP or placebo for a period of two weeks. Subjects will visit the study site for at least 4 visits: screening, randomization/study inception, end-of-week one, final visit, and unscheduled visits as appropriate. Run In (washout period): Subjects will be required to stop using oral nasal decongestants or first generation antihistamines for 48 hours, second generation antihistamines and Singulair for seven days, systemic corticosteroids for 30 days, and nasal or ocular corticosteroid medications for two weeks. Use of these drugs will also not be allowed during the study. The first dose will be administered at the study site and subjects will be monitored on-site for one hour following dosing. There will be 24-hour on-call telephone access between physician/office staff and study subjects. A Study Flow Chart will be used to facilitate trial management, record completed tasks as well as document their time of completion (See Study Flow Chart and Source Documents-Appendix D). Safety evaluations will include monitoring of subject-reported AEs, measurement of vital signs, and assessment of safety laboratory data. Qualified independent, non-study administration individuals will be selected prior to the start of treatment for the purpose of safety monitoring. 300 subjects will be randomized. Assuming a screen failure test rate of approximately 33%, approximately 450 subjects will be screened. At the conclusion of the study, the CSR will be prepared by the Sponsor, reviewed and approved by the Principal/Coordinator Investigator before submission.

6. Conditions and Keywords

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

Seasonal Allergic Rhinitis

Keywords

SAR, Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STAHIST Investigational Medical Product

Arm Type

Experimental

Arm Description

STAHIST Tablet, dosed one tablet BID

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet, identical appearance to IMP, dosed one tablet BID

Intervention Type

Drug

Intervention Name(s)

STAHIST

Intervention Description

STAHIST dosed one tablet, BID

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo identical in appearance to IMP, dosed one tablet BID

Primary Outcome Measure Information:

Title

Total Symptom Scores (TSS)

Description

Time Frame

Every 12 hours, two weeks trial duration

Secondary Outcome Measure Information:

Title

Adverse Events (AEs) Assessment

Description

B) Report any side effects or adverse drug reactions and rate the severity of any incident.

Time Frame

Every 12 hours, two weeks study duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and females of any ethnic group between 12 and 60 years of age. History of moderate to severe Seasonal Allergic Rhinitis (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 ("S5") that are the focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal drip. Subjects must have an average 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 & 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 the individual will be confirmed by the investigator/designee. Exclusion Criteria: Pregnancy or lactation. Immunotherapy unless at 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. Subject who has used any investigational drugs within 30 days of the screening visit. 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. Subjects with any family relationship to Sponsor, Investigator, or staff of Sponsor or Investigator. A URI within 4 weeks of study inception. Subjects taking beta blockers or tri-cyclic antidepressants will not be allowed to participate in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen J Pollard, MD

Organizational Affiliation

Family Allergy and Asthma Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Atlanta

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

The South Bend Clinic

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46617

Country

United States

Facility Name

Family Allergy and Asthma Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

Family Allergy and Asthma

City

Somerset

State/Province

Kentucky

ZIP/Postal Code

42501

Country

United States

Facility Name

New Horizons Clinical Research

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

National Allergy, Asthma & Urticaria Centers of Charleston, PA

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Pharmaceutical Research and Consulting, Inc

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Central Texas Health Research

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

12. IPD Sharing Statement

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Trial of STAHIST in Seasonal Allergic Rhinitis

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