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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis; Allergic Rhinitis; Non-seasonal Allergic Rhinitis
• Interventions: Drug: AGR tablet; Drug: Placebo (for AGR tablet and/or Active Comparator); Drug: Active Comparator

• Registration Number: NCT01982916
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-13
• Study Start: 2013-12
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-11
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGR & Placebo	AGR tablet	AGR tablet by qd and Placebo by bid for 4 weeks
AGR & Placebo	Placebo (for AGR tablet and/or Active Comparator)	AGR tablet by qd and Placebo by bid for 4 weeks
Active comparator	Placebo (for AGR tablet and/or Active Comparator)	Active Comparator and Placebo by bid for 4 weeks
Active comparator	Active Comparator	Active Comparator and Placebo by bid for 4 weeks
Placebo	Placebo (for AGR tablet and/or Active Comparator)	Placebo by bid for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change of 4NTSS(4 Nasal Total Symptoms score) from baseline	4 weeks

Trial Locations

Locations (9)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of