Clinical Trial to Evaluate the Safety and Efficacy of AGR Tablet as a Treatment of Perennial Allergic Rhinitis in Korean
NCT ID: NCT01982916
Last Updated: 2018-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
324 participants
INTERVENTIONAL
2013-12-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AGR & Placebo
AGR tablet by qd and Placebo by bid for 4 weeks
AGR tablet
Placebo (for AGR tablet and/or Active Comparator)
Placebo
Placebo by bid for 4 weeks
Placebo (for AGR tablet and/or Active Comparator)
Active comparator
Active Comparator and Placebo by bid for 4 weeks
Placebo (for AGR tablet and/or Active Comparator)
Active Comparator
Interventions
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AGR tablet
Placebo (for AGR tablet and/or Active Comparator)
Active Comparator
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
SMG-SNU Boramae Medical Center
OTHER
Samsung Medical Center
OTHER
Kyunghee University Medical Center
OTHER
Konkuk University Medical Center
OTHER
Inha University Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Severance Hospital
OTHER
Ahn-Gook Pharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Chae-Seo Rhee, M.D.
Role: STUDY_CHAIR
Seoul National University Bundang Hospital
Tae-Bin Won, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Dae-Woo Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Hyo-Yeol Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Sung-Wan Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Jin-Kook Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Medical Center
Young-Hyo Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Soo-Whan Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Chang-Hoon Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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AGR_P3
Identifier Type: -
Identifier Source: org_study_id
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