Trials Sponsors Conditions Drugs Pricing

Conditions

Allergic Rhinitis Non-seasonal Allergic Rhinitis Perennial Allergic Rhinitis

Keywords

Allergic RhinitisPerennial Allergic RhinitisNon-seasonal Allergic RhinitisPAR

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

AGR & Placebo

EXPERIMENTAL

AGR tablet by qd and Placebo by bid for 4 weeks

Drug: AGR tabletDrug: Placebo (for AGR tablet and/or Active Comparator)

Placebo

PLACEBO COMPARATOR

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

Interventions

AGR tabletDrug

AGR & Placebo

Placebo (for AGR tablet and/or Active Comparator)Drug

AGR & PlaceboActive comparatorPlacebo

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Males or Females no younger than 12 years.
Patient with a history of perennial allergic rhinitis for at least an year.

Sponsors & Collaborators

Seoul National University Bundang Hospital
Othercollaborator
Konkuk University Medical Center
Othercollaborator
Inha University Hospital

Study Sites (9)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Inha University Hospital

Incheon, 402-751, South Korea

Seoul National University Hospital

Seoul, 110-744, South Korea

Severance Hospital

Seoul, 120-751, South Korea

Kyung Hee University Medical Center

Seoul, 130-872, South Korea

Samsung Medical Center

Seoul, 135-710, South Korea

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

MeSH Terms

Conditions

Rhinitis, AllergicRhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Chae-Seo Rhee, M.D.
Seoul National University Bundang Hospital
STUDY CHAIR
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

Enrollment

324 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 13, 2013

Study Start

December 2013

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

AGR & Placebo

Placebo

Active comparator

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

AGR & Placebo

Placebo

Active comparator

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations