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

NCT01171664 | Completed Phase 2 DMC

• 1 other identifier: 105781-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Phase 2; SAR; STAHIST

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events--report and assess

  Continuous over the two week study period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo containing no active pharmaceutical ingredients

Drug: Placebo

STAHIST

EXPERIMENTAL

STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis

Drug: STAHIST

Interventions

Placebo DRUG

Tablet, one BID

Placebo

STAHIST DRUG

STAHIST in tablet form dosed one BID

STAHIST

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Magna Pharmaceuticals, Inc.: lead

Study Sites (2)

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Family Allergy & Asthma Research Institute

Louisville, Kentucky, 40215, 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 & Asthma Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 26, 2014

Record last verified: 2010-09

Locations

US (2)