Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Magna Pharmaceuticals, Inc.
• Treatments: Chlorpheniramine; Ephedrine; Pseudoephedrine

Criteria

Inclusion Criteria:

• 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.

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 STAHIST.