Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07168720
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event and Serious Adverse Event', 'timeFrame': 'Day2', 'description': 'Incidence rate of Adverse Event and Serious Adverse Event'}], 'secondaryOutcomes': [{'measure': 'Maximum blood concentration', 'timeFrame': '0 to 4 hour after administration', 'description': 'Maximum blood concentration'}, {'measure': 'Ramsay scale', 'timeFrame': '0 minute to 45 minutes after administration', 'description': 'Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 1,2, 3, 4,5,6; the minimum value is 1 , the maximum value is 6, higher scores mean a better outcome.'}, {'measure': 'Sedation Success Rate', 'timeFrame': '0 minute to 45 minutes after administration', 'description': 'Proportion of subjects who will accomplish to start the anesthetic indcution or medical procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preoperative Sedation']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children', 'detailedDescription': "A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial, using Dexmedetomidine Hydrochloride Microneedles as an investigational drug and the Dexmedetomidine Hydrochloride Microneedles blank preparation as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two arms. The subjects should follow designated physician's instructions accurately during the clinical trial period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 2 years to 6 years (inclusive ), any genders;\n* Body weight meeting the criteria:\n* Scheduled to undergo general anesthesia for surgery/procedure\n* American Society of Anesthesiologists（ASA） I\\~II\n* Provide written informed consent from the legal guardian\n\nExclusion Criteria:\n\n* Allergy to any component of the Dexmedetomidine Hydrochloride Microneedle Patch, history of allergy to other sedative drugs, or known allergy to α2-adrenergic receptor-related products or excipients;\n* Having received other sedative-hypnotic or analgesic drugs prior to randomization, where the time since last dose is less than 7 half-lives;\n* History of bronchial asthma, chronic respiratory diseases, or other severe respiratory system diseases;\n* History of neurological diseases such as ischemic encephalopathy encephalopathy, craniocerebral injury, etc., which in the investigator's judgment may affect the evaluation of the investigational product;\n* History of thoracic, cardiac, or brain surgery;\n* Presence of large areas of skin damage or skin conditions unsuitable for topical patch application on the inner aspects of both forearms or the outer aspects of both thighs;\n* Abnormal liver/kidney function test values (ALT or AST \\>1.5 times the upper limit of normal \\[ULN\\], or bilirubin \\>1.5 × ULN, or serum creatinine \\>1.5 × ULN);\n* Severe cardiovascular diseases (e.g., fulminant myocarditis, high-grade or third-degree atrioventricular block, sick sinus syndrome, severe arrhythmia, cardiomyopathy, severe pulmonary hypertension, pulmonary atresia, heart failure);\n* Anemia requiring treatment, as judged by the investigator (hemoglobin \\<80 g/L);\n* Use of highly selective α2 agonists or antagonists prior to randomization, where the time since last dose is less than 7 half-lives;\n* Participation in another clinical trial (meaning having received an investigational drug or device) within 3 months prior to screening;\n* Presence of severe psychiatric illness at screening leading to inability or unwillingness to cooperate;\n* Other situations deemed by the investigator as unsuitable for inclusion."}, 'identificationModule': {'nctId': 'NCT07168720', 'briefTitle': 'The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Novaken Pharm Co., Ltd.'}, 'officialTitle': 'Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children', 'orgStudyIdInfo': {'id': 'BOJI2025016LH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': '16 Participants will receive the Dexmedetomidine hydrochloride Microneedles identified in Part 1 of the study. Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group. A total of 16 children with a high body weight (weight ≥ 19.4 kg) will be included. They will be randomly divided into a medium-pressure group and a low-pressure at a ratio of 1:1.', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride Microneedles']}, {'type': 'EXPERIMENTAL', 'label': 'part2', 'description': 'Participants will receive the dose identified in Part 1 of the study. A total of 24 children with high body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride Microneedles', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'part3', 'description': 'Participants will receive the dose identified in Part 2 of the study. A total of 24 children with low body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride Microneedles', 'Drug: Placebo']}], 'interventions': [{'name': 'Dexmedetomidine hydrochloride Microneedles', 'type': 'DRUG', 'description': 'Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.', 'armGroupLabels': ['Part 1']}, {'name': 'Dexmedetomidine hydrochloride Microneedles', 'type': 'DRUG', 'description': 'In the high weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.\n\nIn the high weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.', 'armGroupLabels': ['part2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.', 'armGroupLabels': ['part2']}, {'name': 'Dexmedetomidine hydrochloride Microneedles', 'type': 'DRUG', 'description': 'In the low weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.\n\nIn the low weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.', 'armGroupLabels': ['part3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.', 'armGroupLabels': ['part3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510632', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Wang, Doctor', 'role': 'CONTACT', 'email': 'haowang@jnu.edu.cn', 'phone': '011-86-15521329479'}], 'facility': 'The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'HuaLiang Liu, Master', 'role': 'CONTACT', 'email': 'liuhl@gznovaken.com', 'phone': '+86+13590957282'}]}, 'ipdSharingStatementModule': {'url': 'http://www.novaken.cn/', 'infoTypes': ['ICF'], 'timeFrame': 'Data are available 6 months after the primary publication', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Novaken Pharm Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}