Trial of STAHIST in Seasonal Allergic Rhinitis

NCT01293201 | Completed Phase 3

• 1 other identifier: 105781-3
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 8

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

SAR; Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 12 hours, two weeks trial duration

Secondary Outcomes (1)

• Adverse Events (AEs) Assessment

  Every 12 hours, two weeks study duration

Study Arms (2)

STAHIST Investigational Medical Product

EXPERIMENTAL

STAHIST Tablet, dosed one tablet BID

Drug: STAHIST

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

STAHIST DRUG

STAHIST dosed one tablet, BID

STAHIST Investigational Medical Product

Placebo DRUG

Placebo identical in appearance to IMP, dosed one tablet BID

Placebo

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Magna Pharmaceuticals, Inc.: lead

Study Sites (8)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Family Allergy and Asthma Institute

Louisville, Kentucky, 40215, United States

Location

Family Allergy and Asthma

Somerset, Kentucky, 42501, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

National Allergy, Asthma & Urticaria Centers of Charleston, PA

Charleston, South Carolina, 29406, United States

Location

Pharmaceutical Research and Consulting, Inc

Dallas, Texas, 75231, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Stephen J Pollard, MD

  Family Allergy and Asthma Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 10, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 2, 2011

Record last verified: 2011-04

Locations

US (8)