NCT01982916

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

November 7, 2013

Last Update Submit

March 11, 2018

Conditions

Allergic RhinitisPerennial Allergic RhinitisNon-seasonal 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

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

Interventions

AGR tabletDRUG
AGR & Placebo
Placebo (for AGR tablet and/or Active Comparator)DRUG
AGR & PlaceboActive comparatorPlacebo
Active ComparatorDRUG
Active comparator

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.
  • Patients able to attend the required number of visits.
  • A normal ECG.

You may not qualify if:

  • 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.
  • Failure to pass properly the washout period of the following period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Seoul National University Bundang Hospital

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

Location

Inha University Hospital

Incheon, 402-751, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital

Seoul, 120-751, South Korea

Location

Kyung Hee University Medical Center

Seoul, 130-872, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

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

  • 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

    PRINCIPAL INVESTIGATOR

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 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

KR(9)