Efficacy and Safety of HCP1102 Capsule

Asthma With Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552667
• Other study ID #: HM-MOLZ-302
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2015
• Last updated: September 16, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma With Allergic Rhinitis

Intervention

Drug:
• HCP1102+HGP0711Placebo
Coadministration of HCP1102 with HGP0711 Placebo for 4-week
• HCP1102Placebo+HGP0711
Coadministration of HCP1102 Placebo with HGP0711 for 4-week

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyunggi -do

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Mean Daytime Nasal Symptom Score		base line, 3-4week(2weeks)	No
Secondary	Change of Mean Daytime Nasal Symptom Score		base line, 1-2week(2weeks), 3-4week(2weeks)	No
Secondary	Change of Runny nose (Mean Daytime Nasal Symptom Score)		base line, 1-2week(2weeks), 3-4week(2weeks)	No
Secondary	Change of Mean Nighttime Nasal Symptom Score		base line, 1-2week(2weeks), 3-4week(2weeks)	No
Secondary	Change of Mean Composite Symptom Score		base line, 1-2week(2weeks), 3-4week(2weeks)	No
Secondary	Change of sneezing (Mean Daytime Nasal Symptom Score)		base line, 1-2week(2weeks), 3-4week(2weeks)	No
Secondary	Change of pruritus (Mean Daytime Nasal Symptom Score)		base line, 1-2week(2weeks), 3-4week(2weeks)	No