Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)

NCT01425827 | Completed DMC

• 1 other identifier: alexmed116619163
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Reduction; Function Improvement

Keywords

duloxetine; osteoarthritis; pain; function

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  16 weeks

Interventions

duloxetine HCL DRUG

60 mg/day duloxetine for 16 weeks

placebo DRUG

similar looking tablets to the active agent for 16 weeks

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis

You may not qualify if:

• inflammatory conditions
• autoimmune disorders
• psychiatric illness
• morbid obesity

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine, University of Alexandria

Alexandria, 00203, Egypt

Location

Related Publications (1)

• Abou-Raya S, Abou-Raya A, Helmii M. Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial. Age Ageing. 2012 Sep;41(5):646-52. doi: 10.1093/ageing/afs072. Epub 2012 Jun 27.

  PMID: 22743149 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anna Abou-Raya, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 30, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

EG (1)