Skip to main content
OpenTrials
Completed

NCT Number: NCT02552667

Efficacy and Safety of HCP1102 Capsule

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyunggi -do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP1102+HGP0711Placebo

Drug

Coadministration of HCP1102 with HGP0711 Placebo for 4-week

HCP1102Placebo+HGP0711

Drug

Coadministration of HCP1102 Placebo with HGP0711 for 4-week

Primary outcomes

  1. Change of Mean Daytime Nasal Symptom Score

    Time frame: base line, 3-4week(2weeks)

Secondary outcomes

  1. Change of Mean Daytime Nasal Symptom Score

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

  2. Change of Runny nose (Mean Daytime Nasal Symptom Score)

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

  3. Change of Mean Nighttime Nasal Symptom Score

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

  4. Change of Mean Composite Symptom Score

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

  5. Change of sneezing (Mean Daytime Nasal Symptom Score)

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

  6. Change of pruritus (Mean Daytime Nasal Symptom Score)

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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2015
Registry last updated
Sep 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.