Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-01-17 @ 10:13 AM
Study NCT ID:
NCT04324918
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Mean Daytime Nasal Symptom Score', 'timeFrame': 'base line, 3-4week(2weeks)', 'description': 'Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).'}], 'secondaryOutcomes': [{'measure': 'Change of Mean Nighttime Nasal Symptom Score', 'timeFrame': 'baseline, 3-4week(2weeks)', 'description': 'Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perennial Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :\n\nA 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 Criteria:\n\n* Patients with at least 2 years history of PAR prior to the study\n* Positive results of skin prick test\n* Patients who provided a signed written informed consent form\n* Patients who are able and willing to complete subject diaries\n* Patients who agree to maintain consistency in their surroundings throughout the study period\n\nExclusion Criteria:\n\n* Patients also with non-allergic rhinitis with different causes.\n* Patients with severe asthma.\n* History of acute • chronic sinusitis within 1 month of Visit 1\n* History of intranasal surgeries within 3 months of Visit 1\n* Initiation of immunotherapy or dose modification within 1 month prior to Visit 1\n* Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.\n* Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.'}, 'identificationModule': {'nctId': 'NCT04324918', 'briefTitle': 'Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial', 'orgStudyIdInfo': {'id': 'HM-MOLZ-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCP1102', 'interventionNames': ['Drug: HCP1102']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HGP1408', 'interventionNames': ['Drug: HGP1408']}], 'interventions': [{'name': 'HCP1102', 'type': 'DRUG', 'description': 'The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.', 'armGroupLabels': ['HCP1102']}, {'name': 'HGP1408', 'type': 'DRUG', 'description': 'The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.', 'armGroupLabels': ['HGP1408']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Su Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}