Ignite Creation Date:
2024-05-05 @ 11:18 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01293201
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2011-02-08
Brief Title:
Trial of STAHIST in Seasonal Allergic Rhinitis
Sponsor:
Magna Pharmaceuticals Inc
Organization:
Magna Pharmaceuticals Inc
Study Overview
Official Title:
A Multi-Center Double-Blind Randomized Placebo-Controlled Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult and Adolescent Subjects With a History of Seasonal Allergic Rhinitis
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall development plan is to show that the combination of tried-and-proven decongestantantihistamine ingredients pseudoephedrine hydrochloride and chlorpheniramine maleate plus a very small amount of belladonna alkaloids 24 mg atropine sulfate is a comprehensive 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 Considering the favorable safety and efficacy results of Phase 1 and Phase 2 the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group Objectives A To report and compare total symptom scores TSS by SAR subjects rating the efficacy of STAHIST vs placebo in relieving nasal congestion rhinorrhea nasal itching sneezing and post-nasal drip over the two-week study period B Report any side effects or adverse drug reactions and rate the severity of any incident C Compare and report each symptom score total nasal symptom scores TNSS and post-nasal drip symptom scores PND-S between the two study arms
Detailed Description:
Phase 3 clinical trial will be conducted in conformance with Good Clinical Practices and is a multi-center double-blind randomized placebo-controlled parallel-group study evaluating the safety and efficacy of STAHIST IMP in 300 adult and adolescent subjects 12-60 years of age of either sex or any race with a minimum 2-year history of seasonal allergic rhinitis SAR and a baseline minimum total symptom score TSS of not less than 8 on the S5 Subject Diary Subjects will be treated twice daily with IMP or placebo for a period of two weeks Subjects will visit the study site for at least 4 visits screening randomizationstudy inception end-of-week one final visit and unscheduled visits as appropriate
Run In washout period Subjects will be required to stop using oral nasal decongestants or first generation antihistamines for 48 hours second generation antihistamines and Singulair for seven days systemic corticosteroids for 30 days and nasal or ocular corticosteroid medications for two weeks Use of these drugs will also not be allowed during the study
The first dose will be administered at the study site and subjects will be monitored on-site for one hour following dosing There will be 24-hour on-call telephone access between physicianoffice staff and study subjects
A Study Flow Chart will be used to facilitate trial management record completed tasks as well as document their time of completion See Study Flow Chart and Source Documents-Appendix D
Safety evaluations will include monitoring of subject-reported AEs measurement of vital signs and assessment of safety laboratory data Qualified independent non-study administration individuals will be selected prior to the start of treatment for the purpose of safety monitoring
300 subjects will be randomized Assuming a screen failure test rate of approximately 33 approximately 450 subjects will be screened
At the conclusion of the study the CSR will be prepared by the Sponsor reviewed and approved by the PrincipalCoordinator Investigator before submission
Run In washout period Subjects will be required to stop using oral nasal decongestants or first generation antihistamines for 48 hours second generation antihistamines and Singulair for seven days systemic corticosteroids for 30 days and nasal or ocular corticosteroid medications for two weeks Use of these drugs will also not be allowed during the study
The first dose will be administered at the study site and subjects will be monitored on-site for one hour following dosing There will be 24-hour on-call telephone access between physicianoffice staff and study subjects
A Study Flow Chart will be used to facilitate trial management record completed tasks as well as document their time of completion See Study Flow Chart and Source Documents-Appendix D
Safety evaluations will include monitoring of subject-reported AEs measurement of vital signs and assessment of safety laboratory data Qualified independent non-study administration individuals will be selected prior to the start of treatment for the purpose of safety monitoring
300 subjects will be randomized Assuming a screen failure test rate of approximately 33 approximately 450 subjects will be screened
At the conclusion of the study the CSR will be prepared by the Sponsor reviewed and approved by the PrincipalCoordinator Investigator before submission
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