NCT02552667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

September 7, 2015

Last Update Submit

September 16, 2015

Conditions

Asthma With Allergic Rhinitis

Keywords

AsthmaAllergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • Change of Mean Daytime Nasal Symptom Score

    base line, 3-4week(2weeks)

Secondary Outcomes (6)

  • Change of Mean Daytime Nasal Symptom Score

    base line, 1-2week(2weeks), 3-4week(2weeks)

  • Change of Runny nose (Mean Daytime Nasal Symptom Score)

    base line, 1-2week(2weeks), 3-4week(2weeks)

  • Change of Mean Nighttime Nasal Symptom Score

    base line, 1-2week(2weeks), 3-4week(2weeks)

  • Change of Mean Composite Symptom Score

    base line, 1-2week(2weeks), 3-4week(2weeks)

  • Change of sneezing (Mean Daytime Nasal Symptom Score)

    base line, 1-2week(2weeks), 3-4week(2weeks)

  • +1 more secondary outcomes

Study Arms (2)

HCP1102+HGP0711Placebo

EXPERIMENTAL

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

Drug: HCP1102+HGP0711Placebo

HCP1102Placebo+HGP0711

ACTIVE COMPARATOR

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

Drug: HCP1102Placebo+HGP0711

Interventions

HCP1102+HGP0711PlaceboDRUG

Coadministration of HCP1102 with HGP0711 Placebo for 4-week

HCP1102+HGP0711Placebo
HCP1102Placebo+HGP0711DRUG

Coadministration of HCP1102 Placebo with HGP0711 for 4-week

HCP1102Placebo+HGP0711

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyunggi -do, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29945738DERIVED

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Choon-Sik Park, M.D., Ph.D.

    Soon Chun Hyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 17, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

KR(1)