Trial record 1 of 74 for:    Open Studies | "Rhinitis, Allergic, Perennial"
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor:
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
Information provided by (Responsible Party):
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01982916
First received: November 7, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
Perennial Allergic Rhinitis
Non-seasonal Allergic Rhinitis
Drug: AGR tablet
Drug: Placebo (for AGR tablet and/or Active Comparator)
Drug: Active Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 4 Week Multicenter, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of AGR Tablet in the Treatment of Perennial Allergic Rhinitis in Korean : a Phase III Clinical Trial Bridging Study

Further study details as provided by Ahn-Gook Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • Change of 4NTSS(4 Nasal Total Symptoms score) from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: December 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGR & Placebo
AGR tablet by qd and Placebo by bid for 4 weeks
Drug: AGR tablet Drug: Placebo (for AGR tablet and/or Active Comparator)
Placebo Comparator: Placebo
Placebo by bid for 4 weeks
Drug: Placebo (for AGR tablet and/or Active Comparator)
Active Comparator: Active comparator
Active Comparator and Placebo by bid for 4 weeks
Drug: Placebo (for AGR tablet and/or Active Comparator) Drug: Active Comparator

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982916

Contacts
Contact: Dong-Han Kim, Senior Researcher 82-2-3289-4240 bebop830@ahn-gook.com
Contact: Myoung-Soo Ko, Senior Researcher 82-8-3289-4236 mckms@ahn-gook.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Min-Hae Bae    +82-31-787-7400      
Principal Investigator: Chae-Seo Rhee, M.D.         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 402-751
Contact: Jin-Young Jang         
Principal Investigator: Young-Hyo Kim, M.D.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Eun-Hwa Choi    +82-8-3410-1249      
Principal Investigator: Hyo-Yeol Kim, M.D.         
Kyung Hee University Medical Center Recruiting
Seoul, Korea, Republic of, 130-872
Contact: Ji-Young Han         
Principal Investigator: Sung-Wan Kim, M.D.         
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 143-729
Contact: Young-Eun Han    +82-2-2030-5296      
Principal Investigator: Jin-Kook Kim, M.D.         
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Ji-Hye Hong    +82-2-870-3894      
Principal Investigator: Dae-Woo Kim, M.D.         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Yoon-Jung Lee    +82-2-2258-7875      
Principal Investigator: Soo-Whan Kim, M.D.         
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-751
Contact: Yeon Jeoung    +82-2-2228-0445      
Principal Investigator: Chang-Hoon Kim         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Yoon-Sun Hwang    +82-2-2072-3242      
Principal Investigator: Tae-Bin Won, M.D.         
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
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
Investigators
Study Chair: Chae-Seo Rhee, M.D. Seoul National University Bundang Hospital
Principal Investigator: Tae-Bin Won, M.D. Seoul National University Hospital
Principal Investigator: Dae-Woo Kim, M.D. SMG-SNU Boramae Medical Center
Principal Investigator: Hyo-Yeol Kim, M.D. Samsung Medical Center
Principal Investigator: Sung-Wan Kim, M.D. Kyunghee University Medical Center
Principal Investigator: Jin-Kook Kim, M.D. Konkuk University Medical Center
Principal Investigator: Young-Hyo Kim, M.D. Inha University Hospital
Principal Investigator: Soo-Whan Kim, M.D. Seoul St. Mary's Hospital
Principal Investigator: Chang-Hoon Kim, M.D. Severance Hospital
  More Information

No publications provided

Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01982916     History of Changes
Other Study ID Numbers: AGR_P3
Study First Received: November 7, 2013
Last Updated: February 18, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
Allergic Rhinitis
Perennial Allergic Rhinitis
Non-seasonal Allergic Rhinitis
PAR

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014