Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01008397
Status:
WITHDRAWN
Last Update Posted:
2014-03-06
First Post:
2009-10-27
Brief Title:
Study of AHIST in Seasonal Allergic Rhinitis Patients
Sponsor:
Magna Pharmaceuticals Inc
Organization:
Magna Pharmaceuticals Inc
Study Overview
Official Title:
Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients
Status:
WITHDRAWN
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Manufacturer unable to produce
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ingredients 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
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 ingredients 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
Detailed Description:
This Phase 1 clinical trial will be a single dose pharmacokinetics study comprised of 21 individuals with five blood draws over a 12 hour period Additionally subjects will subjectively score symptom relief and report any side effects from the single dose of AHIST Schulman Associates Institutional Review Board Cincinnati OH will approve the study protocol and statement of informed consent Each study participant will give written informed consent See Attachment A Safety will be assured through close observation and physical examination of subjects before during and at study conclusion This interventional study will be conducted during the spring allergy season of 2010
MAGNA plans to show that chlorpheniramine tannate is a safe and effective BID drug treatment regimen indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older Treated symptoms include nasal congestion sneezing rhinorrhea itchy nose itchywatery eyes and post nasal drip syndrome reduction in tickly cough acute or chronic mucus in the back of the throat sore throat and hoarseness
MAGNA plans to show that chlorpheniramine tannate is a safe and effective BID drug treatment regimen indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older Treated symptoms include nasal congestion sneezing rhinorrhea itchy nose itchywatery eyes and post nasal drip syndrome reduction in tickly cough acute or chronic mucus in the back of the throat sore throat and hoarseness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None