Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-25 @ 2:18 AM
Study NCT ID:
NCT02307305
Status:
UNKNOWN
Last Update Posted:
2016-02-19
First Post:
2014-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'C478659', 'term': 'Ultracet'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2014-11-27', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Numeric rating scale for pain (NRS)', 'timeFrame': '6 months'}, {'measure': 'American Knee Society knee and function score', 'timeFrame': '6 months'}, {'measure': 'Western Ontario and McMaster University Arthritis Index (WOMAC)', 'timeFrame': '6 months'}, {'measure': 'Geriatric depression scale-short form', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).\n\nInvestigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.', 'detailedDescription': 'Both groups of participants will receive pain control regimens as follows:\n\nPreemptive analgesia : celebrex celecoxib, Patient controlled analgesia (postoperation 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)\n\nDrug generic names: celecoxib (celebrex), naproxen/esomeprazole (vimovo), acetaminophen/tramadol (ultracet ER), oxycodone/naloxone (targin)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis of knee requiring TKA\n\nExclusion Criteria:\n\n* Rheumatoid arthritis\n* Other inflammatory arthritis\n* Neuropsychiatric patients\n* Hepatic insufficiency\n* Renal insufficiency\n* Patients older than 75\n* Allergy or intolerance to study medications\n* Patients with an ASA of IV (angina, congestive heart failure, dementia, cerebrovascular accident)\n* Chronic gabapentin or pregabalin use (regular use for longer than 3 months)\n* Chronic opioid use (taking opioids for longer than 3 months)'}, 'identificationModule': {'nctId': 'NCT02307305', 'briefTitle': 'Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University Seoul Hospital'}, 'officialTitle': 'Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?', 'orgStudyIdInfo': {'id': 'cymbaltaTKR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetin group', 'description': '1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day)\n2. Phase II (titration): POD#1\\~6 (30mg for another 6 days)\n3. Phase III (maintenance): POD#7\\~13(60mg for 7 days)\n4. Phase IV (tapering-1): POD#14\\~20 (30mg for 7 days)\n5. Phase V (tapering-2): POD#21\\~27 (30mg another every day for 7 days)\n\nplus routine pain control (celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone)', 'interventionNames': ['Drug: Duloxetine', 'Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'routine pain control group', 'description': 'Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)\n\nOther name of drugs: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone', 'interventionNames': ['Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['cymbalta'], 'description': '1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day)\n2. Phase II (titration): POD#1\\~6 (30mg for another 6 days)\n3. Phase III (maintenance): POD#7\\~13(60mg for 7 days)\n4. Phase IV (tapering-1): POD#14\\~20 (30mg for 7 days)\n5. Phase V (tapering-2): POD#21\\~27 (30mg another every day for 7 days)', 'armGroupLabels': ['Duloxetin group']}, {'name': 'celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone', 'type': 'DRUG', 'otherNames': ['celebrex, vimovo, ultracet, targin'], 'description': 'Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)', 'armGroupLabels': ['Duloxetin group', 'routine pain control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133-792', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jinkyu Lee', 'role': 'CONTACT', 'email': 'gaia-silver@hanmail.net', 'phone': '+82-10-9582-7004'}], 'facility': 'Department of Orthopaedic Surgery, Hanyang University, College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jinkyu Lee', 'role': 'CONTACT', 'email': 'gaia-silver@hanmail.net', 'phone': '+82-10-9582-7004'}, {'name': 'Changhoon Lee', 'role': 'CONTACT', 'email': 'toyessay@hanmail.net', 'phone': '+82-10-8635-6990'}], 'overallOfficials': [{'name': 'Choonghyeok Choi', 'role': 'STUDY_CHAIR', 'affiliation': 'Hanyang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University Seoul Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'JIN KYU LEE', 'investigatorAffiliation': 'Hanyang University Seoul Hospital'}}}}