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Study of AHIST in Seasonal Allergic Rhinitis Patients

NCT01008397 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-03-06

No results posted yet for this study

Summary

Objectives:

A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients in AHIST over the dosage interval period of 12 hours.

Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window data);

B) To report subjective scores by subjects rating the efficacy of a single dose AHIST in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a 12-hour dosage interval.

Hypothesis: Greater than 66% of subjects will document clinically significant relief over a 12-hour period from one dose of AHIST;

C) Report any side effects or adverse drug reactions and rate the severity of any incidence.

Hypothesis: Not more than one patient will have an adverse event significant enough to warrant withdrawal; side effects will be mild with the most frequently reported side effect occurring in less than 10% of patients-drowsiness.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

AHIST NDC#58407-012-01

Oral tablet containing chlorpheniramine tannate 12mg.

Sponsors & Collaborators

  • Magna Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen J Pollard, MD · Family Allergy and Asthma Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008397 on ClinicalTrials.gov