Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT02696369
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2016-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain visual analogue scale (VAS)', 'timeFrame': 'Immediately after the extraction', 'description': 'To acess the pain immediately after the surgical extraction of impacted lower third molars'}], 'secondaryOutcomes': [{'measure': 'Onset time of anesthesia', 'timeFrame': 'Immediately after administration of IP'}, {'measure': 'Local anesthetic duration', 'timeFrame': 'Immediately after onset of anesthesia'}, {'measure': 'Pain VAS', 'timeFrame': '2, 4, 6 hours after administration of the investigational product (IP)'}, {'measure': 'Onset time of pain after administration of IP', 'timeFrame': 'Immediately after injection'}, {'measure': 'Bleeding after extraction measured by the operator', 'timeFrame': 'Immediately after extraction'}, {'measure': 'Questionnaire of satisfaction level of the operator', 'timeFrame': 'Immediately after extraction'}, {'measure': 'Questionnaire of satisfaction level of the subjects', 'timeFrame': 'Immediately after extraction'}, {'measure': 'Dosage of administrated IP', 'timeFrame': 'immediately after injection'}]}, 'conditionsModule': {'conditions': ['Third Molar']}, 'descriptionModule': {'briefSummary': 'This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted lower third molars'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 19\n* Physical grade 1 or 2 by American Society of Anesthesiologists (ASA)\n* Mesioangular or horizontal angulation categorized by winter classification\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity about the investigated products\n* Any infection or edema during the extraction\n* The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders\n* Pregnancy or breast-feeding\n* Any conditions that the investigator considers not to appropriate for this study'}, 'identificationModule': {'nctId': 'NCT02696369', 'briefTitle': 'Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars', 'organization': {'class': 'INDUSTRY', 'fullName': 'Huons Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars', 'orgStudyIdInfo': {'id': 'HU-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2% Lidocaine HCL:Epinephrine inj.', 'description': '2% Lidocaine HCL with epinephrine 1:200,000', 'interventionNames': ['Drug: 2% lidocaine HCl with epinephrine 1:200,000']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2% Lidocaine HCL:Epinephrine inj. (3M)', 'description': '2% Lidocaine HCl with epinephrine 1:80,000', 'interventionNames': ['Drug: 2% lidocaine HCl with epinephrine 1:80,000']}], 'interventions': [{'name': '2% lidocaine HCl with epinephrine 1:200,000', 'type': 'DRUG', 'armGroupLabels': ['2% Lidocaine HCL:Epinephrine inj.']}, {'name': '2% lidocaine HCl with epinephrine 1:80,000', 'type': 'DRUG', 'armGroupLabels': ['2% Lidocaine HCL:Epinephrine inj. (3M)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '426791', 'city': 'Ansan', 'state': 'Kyeonggi-do', 'country': 'South Korea', 'facility': 'Huons', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huons Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}