Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-26 @ 5:00 PM
Study NCT ID:
NCT01307969
Status:
COMPLETED
Last Update Posted:
2011-03-03
First Post:
2011-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Formulations of Liposomal Local Anesthetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D008081', 'term': 'Liposomes'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008567', 'term': 'Membranes, Artificial'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D004337', 'term': 'Drug Carriers'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D040761', 'term': 'Biomimetic Materials'}, {'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'}, {'id': 'D000083', 'term': 'Acetanilides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-02', 'studyFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2011-03-02', 'lastUpdatePostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'After anesthetic injection the pulpal response was assessed by an electrical pulp tester.', 'timeFrame': '100 minutes'}], 'secondaryOutcomes': [{'measure': 'Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.', 'timeFrame': '240 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['liposomes', 'ropivacaine', 'dental anesthesia', 'dentistry'], 'conditions': ['Underdosing of Local Anesthetics, Initial Encounter']}, 'referencesModule': {'references': [{'pmid': '21831487', 'type': 'DERIVED', 'citation': 'Franz-Montan M, de Paula E, Groppo FC, Ranali J, Volpato MC. Efficacy of liposome-encapsulated 0.5% ropivacaine in maxillary dental anaesthesia. Br J Oral Maxillofac Surg. 2012 Jul;50(5):454-8. doi: 10.1016/j.bjoms.2011.07.010. Epub 2011 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.', 'detailedDescription': 'This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n\nExclusion Criteria:\n\n* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics'}, 'identificationModule': {'nctId': 'NCT01307969', 'briefTitle': 'Formulations of Liposomal Local Anesthetics', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Formulations of Liposomal Local Anesthetics for Dental Anesthesia', 'orgStudyIdInfo': {'id': '164/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anesthetic efficacy', 'description': 'Local anesthetics were injected at the apex of the maxillary right canine.', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['0,5% ropivacaine encapsulated in liposomes', '0,5% ropivacaine with epinephrine 1:200.000', '2% lidocaine with epinephrine 1:100.000'], 'description': '1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.', 'armGroupLabels': ['Anesthetic efficacy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Piracicaba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Piracicaba Dental School', 'geoPoint': {'lat': -22.72528, 'lon': -47.64917}}], 'overallOfficials': [{'name': 'Michelle Franz-Montan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Researcher at Unicamp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Michelle Franz-Montan', 'oldOrganization': 'Unicamp'}}}}