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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1
Gangnam Severance Hospital.
Seoul, South Korea