Ignite Creation Date:
2025-12-17 @ 4:06 PM
Ignite Modification Date:
2025-12-23 @ 11:01 PM
Study NCT ID:
NCT00747669
Status:
SUSPENDED
Last Update Posted:
2012-03-23
First Post:
2008-09-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Synera™ in Neonates and Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D013748', 'term': 'Tetracaine'}, {'id': 'D057968', 'term': 'Transdermal Patch'}], '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': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}}, 'statusModule': {'whyStopped': 'Difficulty with enrollment', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-22', 'studyFirstSubmitDate': '2008-09-03', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera', 'timeFrame': '30 hours'}], 'secondaryOutcomes': [{'measure': 'Monitor the nature and frequency of adverse events', 'timeFrame': '30 Hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.\n* Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.\n* Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.\n* The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.\n\nExclusion Criteria:\n\n* Subject has known allergies or sensitivities to any component of Synera.\n* Subject has clinically significant laboratory abnormalities.\n* Subject has known multiple allergies that could indicate hypersensitive skin.\n* Subject has known active atopic dermatitis at or near the patch application site.'}, 'identificationModule': {'nctId': 'NCT00747669', 'briefTitle': 'Pharmacokinetic Study of Synera™ in Neonates and Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZARS Pharma Inc.'}, 'officialTitle': 'A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants', 'orgStudyIdInfo': {'id': 'EN3274-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lidocaine 70mg and tetracaine 70mg topical patch', 'type': 'DRUG', 'otherNames': ['Synera'], 'description': 'One Synera Patch applied for 30 minutes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'ZARS Clinical Development', 'role': 'STUDY_CHAIR', 'affiliation': 'ZARS Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZARS Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}