Efficacy and Safety of HCP1102 Capsule

Phase 3

Completed

• Conditions: Asthma With Allergic Rhinitis
• Interventions: Drug: HCP1102+HGP0711Placebo; Drug: HCP1102Placebo+HGP0711

• Registration Number: NCT02552667
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-16
• Last Update Submitted: 2015-09-16
• Study First Posted: 2015-09-17
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCP1102+HGP0711Placebo	HCP1102+HGP0711Placebo	HCP1102Placebo+HGP0711Placebo(1week) -\> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily
HCP1102Placebo+HGP0711	HCP1102Placebo+HGP0711	HCP1102Placebo+HGP0711Placebo(1week) -\> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily

Primary Outcome Measures

Name	Time	Method
Change of Mean Daytime Nasal Symptom Score	base line, 3-4week(2weeks)

Secondary Outcome Measures

Name	Time	Method
Change of Runny nose (Mean Daytime Nasal Symptom Score)	base line, 1-2week(2weeks), 3-4week(2weeks)
Change of pruritus (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 Daytime 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)

Trial Locations

Locations (1)

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Gyunggi -do, Korea, Republic of