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Completed

NCT Number: NCT01982916

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

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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Non-seasonal Allergic Rhinitis Nose Diseases Otorhinolaryngologic Diseases Perennial Allergic Rhinitis Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AGR tablet

Drug

Placebo (for AGR tablet and/or Active Comparator)

Drug

Active Comparator

Drug

Primary outcomes

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Collaborators

  • Inha University Hospital
  • Konkuk University Medical Center
  • Kyunghee University Medical Center
  • SMG-SNU Boramae Medical Center
  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Seoul St. Mary's Hospital
  • Severance Hospital

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2013
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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