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

March 26, 2020 updated by: Hanmi Pharmaceutical Company Limited

Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HCP1102
Drug: HCP1102
The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
ACTIVE_COMPARATOR: HGP1408
Drug: HGP1408
The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Mean Daytime Nasal Symptom Score
Time Frame: base line, 3-4week(2weeks)
Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).
base line, 3-4week(2weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Mean Nighttime Nasal Symptom Score
Time Frame: baseline, 3-4week(2weeks)
Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night).
baseline, 3-4week(2weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Kyung-Su Kim, M.D., Ph.D., Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 23, 2018

Primary Completion (ACTUAL)

June 24, 2019

Study Completion (ACTUAL)

June 24, 2019

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-MOLZ-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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