Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05266027
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2022-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Naldebain for Pain Management After Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2022-02-20', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)', 'timeFrame': 'Post operation Day1', 'description': 'morphine consumption amount'}, {'measure': 'The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)', 'timeFrame': 'Post operation Day2', 'description': 'morphine consumption amount'}, {'measure': 'The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)', 'timeFrame': 'Post operation Day3', 'description': 'morphine consumption amount'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Baseline', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Post operation Day1', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Post operation Day2', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Post operation Day3', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Post operation Day4', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Post operation Day5', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Post operation 2 weeks', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}, {'measure': 'The level of pain index (Visual Analog Scale)', 'timeFrame': 'Post operation 6 weeks', 'description': 'pain level, Visual Analog Scale higher scores mean a worse outcome, 0\\~10'}], 'secondaryOutcomes': [{'measure': 'knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)', 'timeFrame': 'Baseline', 'description': 'knee joint functional data questionnaire'}, {'measure': 'knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)', 'timeFrame': 'Post operation 2 weeks', 'description': 'knee joint functional data questionnaire'}, {'measure': 'knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)', 'timeFrame': 'Post operation 6 weeks', 'description': 'knee joint functional data questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthropathy of Knee Joint']}, 'descriptionModule': {'briefSummary': "Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. This study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .", 'detailedDescription': "Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. At present, it is the only analgesic injection that has an efficacy of up to seven days. The currently approved drug indication is to relieve moderate and severe acute pain after surgery. Pharmacological mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its side effects are much lower than morphine. Because of its special pharmacological mechanism, it has extremely high potential to improve patients undergoing knee replacement surgery. Therefore, this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 50 years old, not exceed 100 years old\n* Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty\n\nExclusion Criteria:\n\n* Diagnosed inflammatory Arthritis、Rheumatoid Arthritis\n* Accepted Revision Knee Arthroplasty\n* Patients with head injury, intracranial injury, increased intracerebral pressure and liver insufficiency\n* Patients who are allergic to nalbuphine sebacate, nalbuphine, sesame oil or benzyl benzoate drugs'}, 'identificationModule': {'nctId': 'NCT05266027', 'briefTitle': 'Naldebain for Pain Management After Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'KMUHIRB-F(I)-20210150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Nalbuphine Sebacate (Naldebain) intramuscular injection', 'interventionNames': ['Drug: Nalbuphine Sebacate (Naldebain)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo medication intramuscular injection', 'interventionNames': ['Drug: Placebo medication']}], 'interventions': [{'name': 'Nalbuphine Sebacate (Naldebain)', 'type': 'DRUG', 'description': 'Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Placebo medication', 'type': 'DRUG', 'description': 'Placebo medication, Nalbuphine Sebacate not contained', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Hsuan-Ti Huang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kaohsiung Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}