Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT07287735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment (Two-arm - GOPRELTO vs. NUMBRINO)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-06', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 through Day 8-10', 'description': 'Number of subjects experiencing at least one treatment-emergent adverse event after administration of study drug.'}, {'measure': 'Change in Systolic Blood Pressure From Pre-Dose', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean change from baseline in systolic blood pressure (mmHg).'}, {'measure': 'Change in Diastolic Blood Pressure From Pre-Dose', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean change from baseline in diastolic blood pressure (mmHg).'}, {'measure': 'Change in Heart Rate From Pre-Dose', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean change from baseline in heart rate (beats per minute).'}, {'measure': 'Change in Respiratory Rate From Pre-Dose', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean change from baseline in respiratory rate (breaths per minute).'}, {'measure': 'Change in Oxygen Saturation (SpO₂)', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean change in pulse oximetry oxygen saturation (% SpO₂).'}, {'measure': 'ECG QT Interval', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean QT interval (milliseconds) obtained from 12-lead ECG.'}, {'measure': 'ECG PR Interval', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean PR interval (milliseconds).'}, {'measure': 'ECG QRS Duration', 'timeFrame': 'Pre-dose to 24 hours post-dose', 'description': 'Mean QRS duration (milliseconds).'}, {'measure': 'Peak Plasma Concentration (Cmax) of Cocaine', 'timeFrame': 'Day 1 (pre-dose to end of PK sampling)', 'description': 'Maximum observed plasma concentration of cocaine (ng/mL)'}, {'measure': 'Time to Peak Concentration (Tmax) of Cocaine', 'timeFrame': 'Day 1 (pre-dose to end of PK sampling)', 'description': 'Time to reach maximum plasma concentration (hours).'}, {'measure': 'Area Under the Concentration-Time Curve (AUC₀-t) for Cocaine', 'timeFrame': 'Day 1 (pre-dose to end of PK sampling)', 'description': 'Area under the plasma concentration-time curve from time zero to last measurable concentration (ng·hr/mL).'}, {'measure': 'Area Under the Concentration-Time Curve (AUC₀-∞) for Cocaine', 'timeFrame': 'Day 1 (pre-dose to end of PK sampling)', 'description': 'AUC extrapolated to infinity (ng·hr/mL).'}, {'measure': 'Plasma Half-Life (t½) of Cocaine', 'timeFrame': 'Day 1 (pre-dose to end of PK sampling)', 'description': 'Elimination half-life (hours).'}, {'measure': 'Apparent Clearance (CL/F) of Cocaine', 'timeFrame': 'Day 1', 'description': 'Apparent plasma clearance (L/hour).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GOPRELTO', 'NUMBRINO', 'Cocaine Hydrochloride Nasal Solution', 'Pediatric Local Anesthesia'], 'conditions': ['Nasal Procedures', 'Nasal Anesthesia', 'Nasal Mucosa Surgery']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209963lbl.pdf', 'label': 'Full Prescribing Information - GOPRELTO®'}, {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209575s000lbl.pdf', 'label': 'Full Prescribing Information - NUMBRINO™'}]}, 'descriptionModule': {'briefSummary': 'This open-label, two-arm, single-dose clinical study evaluates the pharmacokinetics, safety, and tolerability of GOPRELTO® (cocaine hydrochloride nasal solution 4%) and NUMBRINO™ (cocaine hydrochloride nasal solution 4%) in pediatric subjects aged 12 to \\<18 years undergoing diagnostic procedures or surgeries on or through the nasal mucous membranes. Up to 20 subjects will receive GOPRELTO® and up to 20 will receive NUMBRINO™.', 'detailedDescription': '"GOPRELTO® and NUMBRINO™ are FDA-approved in adults for induction of local anesthesia of the mucous membranes during diagnostic procedures and surgeries. This Phase IIIb study assesses PK, safety, and tolerability in pediatric subjects using weight-based dosing applied via cottonoid pledgets. Plasma samples will be collected for PK, and standard safety assessments including vital signs, ECGs, pulse oximetry, laboratory tests, and adverse events will be performed."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 12 to \\<18 years\n\n * Weight ≥10th percentile; BMI ≥5th percentile\n * Oxygen saturation ≥98%\n * Undergoing nasal diagnostic procedure or surgery\n * Able to assent; parent/guardian able to provide consent\n * Use of acceptable contraception (if applicable)\n\nExclusion Criteria:\n\n* History of seizure\n\n * Hypersensitivity to cocaine or ester anesthetics\n * Recent intranasal cocaine use\n * Positive drug screen\n * Use of prohibited medications (SSRIs, MAOIs, decongestants, stimulants, etc.)\n * Cardiovascular disease, abnormal ECG\n * Hepatic or renal disease\n * Nasal mucosa trauma preventing pledget placement'}, 'identificationModule': {'nctId': 'NCT07287735', 'briefTitle': 'Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Omnivium Pharmaceuticals LLC'}, 'officialTitle': 'An Open-label, Two-arm Study Evaluating Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO Nasal Solutions in Pediatric Subjects Undergoing Nasal Diagnostic Procedures or Surgeries From ≥12 Years to <18 Years of Age.', 'orgStudyIdInfo': {'id': 'RA-VP-000-357'}, 'secondaryIdInfos': [{'id': 'IND118527 and IND 106499', 'type': 'OTHER', 'domain': 'U.S. IND number for each investigational product.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Name: GOPRELTO®', 'description': 'Single topical dose administered via cottonoid pledgets for 20 minutes.', 'interventionNames': ['Drug: GOPRELTO®']}, {'type': 'EXPERIMENTAL', 'label': 'Name: NUMBRINO™', 'description': 'Single topical dose administered via cottonoid pledgets for 20 minutes.', 'interventionNames': ['Drug: NUMBRINO™']}], 'interventions': [{'name': 'GOPRELTO®', 'type': 'DRUG', 'description': 'cocaine hydrochloride nasal solution 4%', 'armGroupLabels': ['Name: GOPRELTO®']}, {'name': 'NUMBRINO™', 'type': 'DRUG', 'description': 'cocaine hydrochloride nasal solution 4%', 'armGroupLabels': ['Name: NUMBRINO™']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr. Robert Puchalski, Principal Investigator, MD', 'role': 'CONTACT', 'email': 'rpuchalski@southcarolinaent.com', 'phone': 'South Carolina ENT, Allergy &', 'phoneExt': '(803) 549-2467'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Omnivium Pharmaceuticals LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}