Efficacy and Safety of HCP1102 Capsule

September 16, 2015 updated by: Hanmi Pharmaceutical Company Limited

Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

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

  • Korea, Republic of
    • Gyunggi -do
      • Bucheon, Gyunggi -do, Korea, Republic of
        • Soon Chun Hyang University Hospital Bucheon

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:

  • 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

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+HGP0711Placebo
HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily
Drug: HCP1102+HGP0711Placebo
Coadministration of HCP1102 with HGP0711 Placebo for 4-week
ACTIVE_COMPARATOR: HCP1102Placebo+HGP0711
HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily
Drug: HCP1102Placebo+HGP0711
Coadministration of HCP1102 Placebo with HGP0711 for 4-week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of Mean Daytime Nasal Symptom Score
Time Frame: base line, 3-4week(2weeks)
base line, 3-4week(2weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Mean Daytime Nasal Symptom Score
Time Frame: base line, 1-2week(2weeks), 3-4week(2weeks)
base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Runny nose (Mean Daytime Nasal Symptom Score)
Time Frame: base line, 1-2week(2weeks), 3-4week(2weeks)
base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Nighttime Nasal Symptom Score
Time Frame: base line, 1-2week(2weeks), 3-4week(2weeks)
base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Composite Symptom Score
Time Frame: base line, 1-2week(2weeks), 3-4week(2weeks)
base line, 1-2week(2weeks), 3-4week(2weeks)
Change of sneezing (Mean Daytime Nasal Symptom Score)
Time Frame: base line, 1-2week(2weeks), 3-4week(2weeks)
base line, 1-2week(2weeks), 3-4week(2weeks)
Change of pruritus (Mean Daytime Nasal Symptom Score)
Time Frame: base line, 1-2week(2weeks), 3-4week(2weeks)
base line, 1-2week(2weeks), 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: Choon-Sik Park, M.D., Ph.D., Soon Chun Hyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2014

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (ESTIMATE)

September 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-MOLZ-302

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.

Subscribe