Clinical trial NCT01982916: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Perennial Allergic Rhinitis
Non-seasonal Allergic Rhinitis
Keywords: Allergic Rhinitis
Perennial Allergic Rhinitis
Non-seasonal Allergic Rhinitis
PAR
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Hospital
name: SMG-SNU Boramae Medical Center
name: Samsung Medical Center
name: Kyunghee University Medical Center
name: Konkuk University Medical Center
name: Inha University Hospital
name: Seoul St. Mary's Hospital
name: Severance Hospital
First posted: 2013-11-13
Enrollment: 324
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change of 4NTSS(4 Nasal Total Symptoms score) from baseline
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chae-Seo Rhee, M.D.
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Tae-Bin Won, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Dae-Woo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Hyo-Yeol Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Medical Center
name: Sung-Wan Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Medical Center
name: Jin-Kook Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Young-Hyo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital
name: Soo-Whan Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Chang-Hoon Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: