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

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ClinicalTrials.gov Identifier: NCT01982916
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : March 13, 2018
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

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2013
Actual Primary Completion Date : January 2015
Study Completion Date : January 2015

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change of 4NTSS(4 Nasal Total Symptoms score) from baseline [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982916


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Inha University Hospital
Incheon, Korea, Republic of, 402-751
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital
Seoul, Korea, Republic of, 120-751
Kyung Hee University Medical Center
Seoul, Korea, Republic of, 130-872
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
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

Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01982916     History of Changes
Other Study ID Numbers: AGR_P3
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases