{"type":"trials","record":{"id":41278,"source_id":"clinicaltrials-gov","external_id":"NCT01425827","title":"Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)","brief_summary":"Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options have had limited symptomatic effect and are associated with significant side effects. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have, besides its antidepressant properties, a centrally acting analgesic effect. The aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA. 288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary knee OA attending the outpatient clinic of our institution were enrolled in this study. All patients underwent a physical examination and where questioned about the number of flares. Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included improvements in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline and at monthly intervals for 4 months. All staff involved in data collection was blinded to the treatment assignment groups.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Alexandria","enrollment":288,"countries":["Egypt"],"start_date":"2010-11-01","completion_date":"2011-07-01","last_update_date":"2011-08-30","source_url":"https://clinicaltrials.gov/study/NCT01425827","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:26.536053+00:00","last_seen_at":"2026-09-25T03:10:58.794+00:00","metadata":{"acronym":null,"organization":"University of Alexandria","source_has_results":false},"controlled_terms":["Pain Reduction","Function Improvement","duloxetine HCL","placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":35,"publication_state":"published","match_explanation":"Title contains controlled term: osteoarthritis.","quality_checked_at":"2026-09-25T03:11:01.385369+00:00","duplicate_cluster_key":"id:nct01425827","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2010-11-01 to 2011-07-01","comparator":null,"confidence":"structured-source","population":null,"provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T03:39:00.171371+00:00","intervention":[],"participants":288,"study_design":"INTERVENTIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":[],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"joint-cartilage-aging","is_published":true,"match_reasons":["Title contains controlled term: osteoarthritis.","Abstract contains controlled term: osteoarthritis.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Joint and cartilage ageing","slug":"joint-cartilage-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41278","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}