Efficacy and Safety of HCP1102 Capsule

NCT ID: NCT02552667

Last Updated: 2015-09-17

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

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-07-31

Brief Summary

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Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Detailed Description

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Conditions

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Asthma With 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+HGP0711Placebo

HCP1102Placebo+HGP0711Placebo(1week) -\> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily

Group Type EXPERIMENTAL

HCP1102+HGP0711Placebo

Intervention Type DRUG

Coadministration of HCP1102 with HGP0711 Placebo for 4-week

HCP1102Placebo+HGP0711

HCP1102Placebo+HGP0711Placebo(1week) -\> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily

Group Type ACTIVE_COMPARATOR

HCP1102Placebo+HGP0711

Intervention Type DRUG

Coadministration of HCP1102 Placebo with HGP0711 for 4-week

Interventions

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HCP1102+HGP0711Placebo

Coadministration of HCP1102 with HGP0711 Placebo for 4-week

Intervention Type DRUG

HCP1102Placebo+HGP0711

Coadministration of HCP1102 Placebo with HGP0711 for 4-week

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age≥15
* Mild or moderate asthma patients with allergic rhinitis
* Patient who meet all criteria of rhinitis
* Patients understood the contents and purpose of this trial and signed informed consent form
* Patients who are capable and willing to write subject diary
* Patients who agree with maintain same environment during clinical trials

Exclusion:

* Nonallergic rhinitis
* Severe asthma
* Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma
* Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety
* Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption
* Alcohol abuse or Drug abuse
* Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
* pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives
* Patient who administered other investigational products within 30 days
* Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons
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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Choon-Sik Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Soon Chun Hyang University

Locations

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Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyunggi -do, South Korea

Site Status

Countries

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South Korea

References

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Kim MK, Lee SY, Park HS, Yoon HJ, Kim SH, Cho YJ, Yoo KH, Lee SK, Kim HK, Park JW, Park HW, Chung JH, Choi BW, Lee BJ, Chang YS, Jo EJ, Lee SY, Cho YS, Jee YK, Lee JM, Jung J, Park CS. A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis. Clin Ther. 2018 Jul;40(7):1096-1107.e1. doi: 10.1016/j.clinthera.2018.04.021. Epub 2018 Jun 24.

Reference Type DERIVED
PMID: 29945738 (View on PubMed)

Other Identifiers

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HM-MOLZ-302

Identifier Type: -

Identifier Source: org_study_id

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