Overview

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

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborators:
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
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.