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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01982916

Enrollment

324

Registered

2013-11-13

Start date

2013-12-31

Completion date

2015-01-31

Last updated

2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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

Interventions

DRUGAGR tablet

DRUGPlacebo (for AGR tablet and/or Active Comparator)

DRUGActive Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Change of 4NTSS(4 Nasal Total Symptoms score) from baseline	4 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026