Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis
NCT ID: NCT04324918
Last Updated: 2020-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
174 participants
INTERVENTIONAL
2018-10-23
2019-06-24
Brief Summary
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A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HCP1102
HCP1102
The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
HGP1408
HGP1408
The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.
Interventions
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HCP1102
The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
HGP1408
The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
15 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Kyung-Su Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Gangnam Severance Hospital.
Seoul, , South Korea
Countries
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Other Identifiers
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HM-MOLZ-303
Identifier Type: -
Identifier Source: org_study_id
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