NCT01008397

WithdrawnPhase 1

Study of AHIST in Seasonal Allergic Rhinitis Patients

Magna Pharmaceuticals, Inc.Source

Magna Pharmaceuticals, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

AHIST IND

Study Type

interventional

Actual enrollment (reported)

0

Locations

1 country

Sites

1

Timeline

Study Start

April 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

May 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: May 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 27, 2009
Actual (reported)
First Posted
November 5, 2009
Actual (reported)
Study Start
April 2011
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 6, 2014
Status Verified: February 2011
Last Update Submitted: March 4, 2014

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 ingredient in AHIST over the dosage interval period of 12 hours.
April 2011

Secondary Outcomes (1)

To report any side effects or adverse drug reactions and rate the severity of incidence.
April 2011

Study Arms (1)

AHIST for seasonal allergic rhinitis

EXPERIMENTAL

AHIST for SAR: each green tablet contains 12mg chlorpheniramine tannate.

Drug: AHIST NDC#58407-012-01

Interventions

AHIST NDC#58407-012-01Drug

Oral tablet containing chlorpheniramine tannate 12mg.

AHIST for seasonal allergic rhinitis

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male and females of any ethnic group between 18 and 60 years of age.
History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two years.

Sponsors & Collaborators

Magna Pharmaceuticals, Inc.
Industrylead

Study Sites (1)

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40215, United States

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Stephen J Pollard, MD
Family Allergy and Asthma Research Institute
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 27, 2009

First Posted

November 5, 2009

Study Start

April 2011

Date type not reported

This date has not been verified as actual or estimated.

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NCT00483353

Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers

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NCT01171664

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

Phase 2Completed

SYF20ac8d4c302e4ce3b4dc3eb5df2fdacd

An open label, balanced, randomized, single dose, two-treatment, four period, two-sequence, crossover, fully replicate, bioequivalence study comparing Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablet USP 180 mg/240 mg, Manufactured by: Sun Pharmaceutical Industries Limited, India with Allegra-D® 24 HR (Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablets 180 mg + 240 mg) tablets, Distributed by: Chattem Inc., a Sanofi Company Chattanooga, TN 37409-0219, USA, in healthy, adult, human participants under fasting conditions.

Phase 1Not Yet Recruiting

SYFdcaa671127ee4254a944fe41bfc84c8c

An open label, balanced, randomized, single dose, two-treatment, two period, two-sequence, crossover, bioequivalence study comparing Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablet 180 mg/240 mg, Manufactured by: Sun Pharmaceutical Industries Limited, India with Allegra-D® 24 HR (Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablets 180 mg + 240 mg) tablets, Distributed by: Chattem Inc., a Sanofi Company Chattanooga, TN 37409-0219, USA, in healthy, adult, human participants under fed conditions.

Phase 1Not Yet Recruiting

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.

Prior to study drug administration, subjects' good health will be confirmed by medical history, physical examination, and urine dip pregnancy test.

Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established patient 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 AHIST.

Contact the study team to confirm eligibility.

Primary Completion

April 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

May 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 6, 2014

Record last verified: 2011-02

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01008397
Data provider: ClinicalTrials.gov
Source updated: 2014-03-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:53 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

AHIST for seasonal allergic rhinitis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations