Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2014-09-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HCP1102+HGP0711Placebo
HCP1102Placebo+HGP0711Placebo(1week) -\> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily
HCP1102+HGP0711Placebo
Coadministration of HCP1102 with HGP0711 Placebo for 4-week
HCP1102Placebo+HGP0711
HCP1102Placebo+HGP0711Placebo(1week) -\> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily
HCP1102Placebo+HGP0711
Coadministration of HCP1102 Placebo with HGP0711 for 4-week
Interventions
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HCP1102+HGP0711Placebo
Coadministration of HCP1102 with HGP0711 Placebo for 4-week
HCP1102Placebo+HGP0711
Coadministration of HCP1102 Placebo with HGP0711 for 4-week
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Choon-Sik Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Soon Chun Hyang University
Locations
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyunggi -do, South Korea
Countries
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References
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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.
Other Identifiers
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HM-MOLZ-302
Identifier Type: -
Identifier Source: org_study_id
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