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

Pain Reduction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425827
• Other study ID #: alexmed116619163
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: August 27, 2011
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Faculty of Medicine, University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• primary knee osteoarthritis

Exclusion Criteria:

• inflammatory conditions

• autoimmune disorders

• psychiatric illness

• morbid obesity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Function Improvement
• Pain Reduction

Intervention

Drug:
• duloxetine HCL
60 mg/day duloxetine for 16 weeks
• placebo
similar looking tablets to the active agent for 16 weeks

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, University of Alexandria	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction		16 weeks	Yes