Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02552667
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2015-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of HCP1102 Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-16', 'studyFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Mean Daytime Nasal Symptom Score', 'timeFrame': 'base line, 3-4week(2weeks)'}], 'secondaryOutcomes': [{'measure': 'Change of Mean Daytime Nasal Symptom Score', 'timeFrame': 'base line, 1-2week(2weeks), 3-4week(2weeks)'}, {'measure': 'Change of Runny nose (Mean Daytime Nasal Symptom Score)', 'timeFrame': 'base line, 1-2week(2weeks), 3-4week(2weeks)'}, {'measure': 'Change of Mean Nighttime Nasal Symptom Score', 'timeFrame': 'base line, 1-2week(2weeks), 3-4week(2weeks)'}, {'measure': 'Change of Mean Composite Symptom Score', 'timeFrame': 'base line, 1-2week(2weeks), 3-4week(2weeks)'}, {'measure': 'Change of sneezing (Mean Daytime Nasal Symptom Score)', 'timeFrame': 'base line, 1-2week(2weeks), 3-4week(2weeks)'}, {'measure': 'Change of pruritus (Mean Daytime Nasal Symptom Score)', 'timeFrame': 'base line, 1-2week(2weeks), 3-4week(2weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Allergic rhinitis'], 'conditions': ['Asthma With Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '29945738', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion:\n\n* Ageā„15\n* Mild or moderate asthma patients with allergic rhinitis\n* Patient who meet all criteria of rhinitis\n* Patients understood the contents and purpose of this trial and signed informed consent form\n* Patients who are capable and willing to write subject diary\n* Patients who agree with maintain same environment during clinical trials\n\nExclusion:\n\n* Nonallergic rhinitis\n* Severe asthma\n* Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma\n* Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety\n* Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption\n* Alcohol abuse or Drug abuse\n* Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption\n* pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives\n* Patient who administered other investigational products within 30 days\n* Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons"}, 'identificationModule': {'nctId': 'NCT02552667', 'briefTitle': 'Efficacy and Safety of HCP1102 Capsule', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial', 'orgStudyIdInfo': {'id': 'HM-MOLZ-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCP1102+HGP0711Placebo', 'description': 'HCP1102Placebo+HGP0711Placebo(1week) -\\> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily', 'interventionNames': ['Drug: HCP1102+HGP0711Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HCP1102Placebo+HGP0711', 'description': 'HCP1102Placebo+HGP0711Placebo(1week) -\\> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily', 'interventionNames': ['Drug: HCP1102Placebo+HGP0711']}], 'interventions': [{'name': 'HCP1102+HGP0711Placebo', 'type': 'DRUG', 'description': 'Coadministration of HCP1102 with HGP0711 Placebo for 4-week', 'armGroupLabels': ['HCP1102+HGP0711Placebo']}, {'name': 'HCP1102Placebo+HGP0711', 'type': 'DRUG', 'description': 'Coadministration of HCP1102 Placebo with HGP0711 for 4-week', 'armGroupLabels': ['HCP1102Placebo+HGP0711']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'state': 'Gyunggi -do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'overallOfficials': [{'name': 'Choon-Sik Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soon Chun Hyang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}