Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT03653260
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Event Frequency', 'timeFrame': '1 day'}, {'measure': 'Adverse Event Severity', 'timeFrame': '1 day'}, {'measure': 'Comfort of Zingo/Placebo Administration (Wong-Baker)', 'timeFrame': 'immediate after venipunture', 'description': 'Subject (all ages) to assess the level of comfort of Zingo/Placebo administration, measured using the Wong-Baker FACES scale (0-10), where 0 represent No Discomfort and 10 represent Worst Possible Discomfort.'}, {'measure': 'Comfort of Zingo/Placebo Administration (VAS)', 'timeFrame': 'immediate after venipunture', 'description': 'Subject (age 8-12) to assess the level of comfort of Zingo/Placebo administration, measured using VAS pain rating scales (0-100), where 0 represent No Discomfort and 100 represent Worst Possible Discomfort.'}, {'measure': 'Local Adverse Reaction', 'timeFrame': 'Pre-dose (0-1 hour before), immediately after dose, 15 minutes, 30 minutes', 'description': 'Local Adverse Reactions including erythema, edema, pruritus and hemorrhage/petechiae by severity.'}], 'primaryOutcomes': [{'measure': 'Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation', 'timeFrame': 'immediate after venipunture', 'description': "Child's assessment of pain on venipuncture or peripheral venous cannulation (all ages) performed one to three minutes after Zingo/Placebo administration, measured using the Wong-Baker FACES pain rating scale. The scale includes pictures of facial expressions with correlating numerical scale of 0-10, 0 being no hurt and 10 being the worst hurt."}], 'secondaryOutcomes': [{'measure': '100-mm Visual Analogue Scale (VAS)', 'timeFrame': 'immediate after venipunture', 'description': 'Assessment of pain on venipuncture or peripheral venous cannulation by children age 8-12, measured using a 100-mm VAS (0-100) anchored at 0 for "no pain" and at 100 for "worst possible pain."'}, {'measure': 'Response Rate', 'timeFrame': 'immediate after venipunture', 'description': 'Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale'}, {'measure': 'Compliance Score', 'timeFrame': 'immediate after venipunture', 'description': 'Compliance to venipuncture assess by investigator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catheter Site Pain', 'Pain, Acute', 'Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 3-12\n* About to undergo venipuncture or peripheral venous cannulation at the back of the hand or antecubital fossa\n* Have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES scale (age 3-12) and the extremes of pain on a 100 mm visual analog scale (VAS) (ages 8-12)\n* Signed informed consent, cooperative and agree to attend follow-up visits\n\nExclusion Criteria:\n\n* Any medical condition, non-compliance or instability (including but not limited to exceptionally upset, crying, anxiety) that in the judgement of the investigator might adversely affect the conduct of the study\n* Used any (including external or inhaled) sedatives, analgesics, anaesthetics or other agents/device that may affect the efficacy assessment\n* Subjects with tattoos, surgical scars, ports, implantable devices or a skin condition (e.g. excessive body hair) that may have interfered with the placement of Zingo or skin site assessments\n* Active local infection or other skin pathology at the site of venipuncture or peripheral venous cannulation.\n* Venipuncture of peripheral venous cannulation at the proposed site within the prior two weeks (longer if the wound is apparent)\n* Previous history of allergic reactions to any local anaesthetic or tape/adhesive dressing.\n* Participated in a clinical trial within three months prior to administration of study drug, or have already enrolled in a Zingo clinical trial before\n* At the discretion of the investigator, any subjects that may have to be withdrawn from the study'}, 'identificationModule': {'nctId': 'NCT03653260', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children', 'organization': {'class': 'INDUSTRY', 'fullName': "Lee's Pharmaceutical Limited"}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children', 'orgStudyIdInfo': {'id': '2016-ZK-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine (Zingo)', 'description': '0.5mg lidocaine at 20 bar pressure', 'interventionNames': ['Drug: Lidocaine (Zingo)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'no emitted particle at 20 bar pressure, identical in external appearance to Zingo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine (Zingo)', 'type': 'DRUG', 'otherNames': ['Zingo'], 'description': '0.5 mg lidocaine, 20 bar pressure', 'armGroupLabels': ['Lidocaine (Zingo)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo injector, 20 Bar pressure, empty injector', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Children's Medical Center", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Mazhong Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Lee's Pharmaceutical Limited", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Zhaoke (Hefei) Pharmaceutical Limited', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}