Status:

COMPLETED

Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis

Lead Sponsor:

Hanmi Pharmaceutical Company Limited

Conditions:

Perennial Allergic Rhinitis

Eligibility:

All Genders

15+ years

Phase:

PHASE3

Brief Summary

Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial

Eligibility Criteria

Inclusion

  • Patients with at least 2 years history of PAR prior to the study
  • Positive results of skin prick test
  • Patients who provided a signed written informed consent form
  • Patients who are able and willing to complete subject diaries
  • Patients who agree to maintain consistency in their surroundings throughout the study period

Exclusion

  • Patients also with non-allergic rhinitis with different causes.
  • Patients with severe asthma.
  • History of acute • chronic sinusitis within 1 month of Visit 1
  • History of intranasal surgeries within 3 months of Visit 1
  • Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
  • Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
  • Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.

Key Trial Info

Start Date :

October 23 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 24 2019

Estimated Enrollment :

174 Patients enrolled

Trial Details

Trial ID

NCT04324918

Start Date

October 23 2018

End Date

June 24 2019

Last Update

March 27 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Gangnam Severance Hospital.

Seoul, South Korea