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Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCP1102+HGP0711Placebo | Experimental | HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily |
|
| HCP1102Placebo+HGP0711 | Active Comparator | HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1102+HGP0711Placebo | Drug | Coadministration of HCP1102 with HGP0711 Placebo for 4-week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mean Daytime Nasal Symptom Score | base line, 3-4week(2weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Choon-Sik Park, M.D., Ph.D. | Soon Chun Hyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | Gyunggi -do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29945738 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| HCP1102Placebo+HGP0711 | Drug | Coadministration of HCP1102 Placebo with HGP0711 for 4-week |
|
| 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) |
| Change of pruritus (Mean Daytime Nasal Symptom Score) | base line, 1-2week(2weeks), 3-4week(2weeks) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |