Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-28 @ 8:40 PM
Study NCT ID:
NCT01304134
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2011-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-10', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring VAS', 'timeFrame': '3h post-operation', 'description': 'Measuring resting and coughing VAS, assessing the intensity of pain'}, {'measure': 'Measuring VAS', 'timeFrame': '24 hours post operation', 'description': 'Measuring resting and coughing VAS, assessing the intensity of pain'}, {'measure': 'Measuring VAS', 'timeFrame': '48 hours post operation', 'description': 'Measuring resting and coughing VAS, assessing the intensity of pain'}], 'secondaryOutcomes': [{'measure': 'Dosage', 'timeFrame': 'Within 48h', 'description': 'Total dosage of study drugs within 48h.'}, {'measure': 'The dosage of other rescue analgesic drugs used within 48h post-operation.', 'timeFrame': '48hrs', 'description': 'The dosage of other rescue analgesic drugs used within 48h post-operation.'}, {'measure': 'The invalid times and the total times of PCA application', 'timeFrame': '48hrs', 'description': 'The invalid times and the total times of PCA application'}, {'measure': 'Satisfaction degree for analgesia', 'timeFrame': '48hrs', 'description': 'Satisfaction degree for analgesia after the treatment'}, {'measure': 'AE occurrence and abnormal lab value', 'timeFrame': '48hrs', 'description': 'AE and normal lab value will be recorded during the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Other Acute Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of either sex aged 18 to 65 years old, with a standard body weight \\[standard body weight = height (cm) - 100\\] ±15%.\n2. ASA I and II.\n3. Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.\n4. Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.\n5. Patients who are willing to participate in the study and have signed the written informed consent.\n6. Negative pregnancy test result should be obtained for women of child-bearing age.\n\nExclusion Criteria:\n\n1. Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.\n2. Body weight is less than or over ±15% of the standard body weight.\n3. Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).\n4. Medical history of recovering from abnormal surgery anesthesia.\n5. Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).\n6. Esophagus reflux disease.\n7. Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.\n8. Have known hypersensitivity to opioids.\n9. Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.\n10. Patients with shock.\n11. Patients with COPD.\n12. Patients can not understand the VAS or unable to use PCA.\n13. Pregnant or parturient women.'}, 'identificationModule': {'nctId': 'NCT01304134', 'briefTitle': 'Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma (China) Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment', 'orgStudyIdInfo': {'id': 'OXYI09-CN-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxycodone i.v.', 'description': 'To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine i.v.', 'description': 'To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'otherNames': ['Oxycodone Injection'], 'description': 'dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours', 'armGroupLabels': ['Oxycodone i.v.']}, {'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['Morphine Injection'], 'description': 'dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours', 'armGroupLabels': ['Morphine i.v.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100022', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Investigational site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Mundipharma China Ltd.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mundipharma China Ltd.'}, {'name': 'Mundipharma China Ltd.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigational Site Beijing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma (China) Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}