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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982916
• Other study ID #: AGR_P3
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2013
• Last updated: March 11, 2018
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2018
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• AGR tablet

• Placebo (for AGR tablet and/or Active Comparator)

• Active Comparator

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (10)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd	Inha University Hospital, Konkuk University Medical Center, Kyunghee University Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 4NTSS(4 Nasal Total Symptoms score) from baseline		4 weeks