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Clinical Trial to Evaluate the Safety and Efficacy of AGR Tablet as a Treatment of Perennial Allergic Rhinitis in Korean

Primary Purpose

Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

AGR tablet

Placebo (for AGR tablet and/or Active Comparator)

Active Comparator

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis, PAR

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Males or Females no younger than 12 years.
Patient with a history of perennial allergic rhinitis for at least an year.
Patient with a positive prick test performed on the same day or within one year before the inclusion date.Patients had to have a (+) prick test for some allergen responsible for non-seasonal rhinitis.
Patients with a total symptom score before the study of 5 or greater for nasal symptoms only, assessed during inclusion visit.
Patients able to attend the required number of visits.
A normal ECG.

Exclusion Criteria

Patients with non-allergic rhinitis.
Patients with obstructive nasal polyps or significant deviation of nasal septum in the investigator's criterion.
Known hypersensitivity to tested drugs(or similar structure) or any components of the tested drugs.
Asthmatic patients who had experienced an acute clinical attack in the three months previous to the inclusion or who had received or were receiving any type of drug for its prevention or treatment.
Patients receiving desensitization treatment for any perennial allergen at the inclusion time. However, inclusion of subject stopping this treatment during the study period was permitted.
Failure to pass properly the washout period of the following period.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

AGR & Placebo

Placebo

Active comparator

Arm Description

AGR tablet by qd and Placebo by bid for 4 weeks

Placebo by bid for 4 weeks

Active Comparator and Placebo by bid for 4 weeks

Outcomes

Primary Outcome Measures

Change of 4NTSS(4 Nasal Total Symptoms score) from baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT01982916

First Posted

November 7, 2013

Last Updated

March 11, 2018

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Collaborators

Seoul National University Bundang Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center, Samsung Medical Center, Kyunghee University Medical Center, Konkuk University Medical Center, Inha University Hospital, Seoul St. Mary's Hospital, Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01982916

Brief Title

Clinical Trial to Evaluate the Safety and Efficacy of AGR Tablet as a Treatment of Perennial Allergic Rhinitis in Korean

Official Title

A 4 Week Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of AGR Tablet in the Treatment of Perennial Allergic Rhinitis in Korean : a Phase III Clinical Trial Bridging Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

December 2013 (Actual)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis

Keywords

Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis, PAR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

324 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AGR & Placebo

Arm Type

Experimental

Arm Description

AGR tablet by qd and Placebo by bid for 4 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo by bid for 4 weeks

Arm Title

Active comparator

Arm Type

Active Comparator

Arm Description

Active Comparator and Placebo by bid for 4 weeks

Intervention Type

Drug

Intervention Name(s)

AGR tablet

Intervention Type

Drug

Intervention Name(s)

Placebo (for AGR tablet and/or Active Comparator)

Intervention Type

Drug

Intervention Name(s)

Active Comparator

Primary Outcome Measure Information:

Title

Change of 4NTSS(4 Nasal Total Symptoms score) from baseline

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Males or Females no younger than 12 years. Patient with a history of perennial allergic rhinitis for at least an year. Patient with a positive prick test performed on the same day or within one year before the inclusion date.Patients had to have a (+) prick test for some allergen responsible for non-seasonal rhinitis. Patients with a total symptom score before the study of 5 or greater for nasal symptoms only, assessed during inclusion visit. Patients able to attend the required number of visits. A normal ECG. Exclusion Criteria Patients with non-allergic rhinitis. Patients with obstructive nasal polyps or significant deviation of nasal septum in the investigator's criterion. Known hypersensitivity to tested drugs(or similar structure) or any components of the tested drugs. Asthmatic patients who had experienced an acute clinical attack in the three months previous to the inclusion or who had received or were receiving any type of drug for its prevention or treatment. Patients receiving desensitization treatment for any perennial allergen at the inclusion time. However, inclusion of subject stopping this treatment during the study period was permitted. Failure to pass properly the washout period of the following period.

Overall Study Officials: