Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients

NCT00932256 | Completed Phase 1 DMC

• 1 other identifier: STAHIST IND 105781
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase 1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements and blood levels of active ingredients over 12 hours; 2) To report subjective scores by subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse drug reactions and rate the severity of incidence.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (1)

• To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours.

  August 2009

Secondary Outcomes (1)

• To report any side effects or adverse drug reactions and rate the severity of incidence.

  August 2009

Study Arms (1)

STAHIST for seasonal allergic rhinitis

EXPERIMENTAL

STAHIST for seasonal allergic rhinitis: each white, scored tablet contains pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, and atropine sulfate .24mg

Drug: STAHIST NDC #58407-536-01

Interventions

STAHIST NDC #58407-536-01 DRUG

Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.

Also known as: STAHIST NDC#58407-536-01

STAHIST for seasonal allergic rhinitis

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 the ages of 18 and 60 years of age.
• History of moderate to severe SAR for at least one year.
• Subjects' symptoms will include the five symptoms ("S5") that are the focus of this study:
• nasal congestion;
• rhinorrhea;
• nasal itching;
• sneezing;
• post nasal drip.
• Prior to study subjects' good health will be confirmed by medical history and physical examination.
• Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established medical history.

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 STAHIST.

Sponsors & Collaborators

• Magna Pharmaceuticals, Inc.: lead

Study Sites (1)

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40215, United States

Location

Related Publications (1)

• Moffitt EM. Symptomatic management of upper respiratory allergies. J Miss State Med Assoc. 1968 Apr;9(4):159-61. No abstract available.

  PMID: 5640510 RESULT

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 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 3, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

US (1)