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

NCT ID: NCT04324918

Last Updated: 2020-03-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2019-06-24

Brief Summary

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Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :

A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial

Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HCP1102

Group Type EXPERIMENTAL

HCP1102

Intervention Type DRUG

The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.

HGP1408

Group Type ACTIVE_COMPARATOR

HGP1408

Intervention Type DRUG

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.

Intervention Type DRUG

HGP1408

The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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South Korea

Other Identifiers

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HM-MOLZ-303

Identifier Type: -

Identifier Source: org_study_id

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