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

• Sponsor: University of Alexandria (Other)
• Overall Status: Completed
• CT.gov ID: NCT01425827
• Collaborator: (none)
• Enrollment: 288
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 36.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Reduction; Function Improvement	Drug: duloxetine HCL; Drug: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Outcome Measures

Primary Outcome Measures

1. Pain reduction [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• primary knee osteoarthritis

Exclusion Criteria:

• inflammatory conditions

• autoimmune disorders

• psychiatric illness

• morbid obesity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, University of Alexandria	Alexandria		Egypt	00203

Sponsors and Collaborators

• University of Alexandria

Investigators

• Principal Investigator: Anna Abou-Raya, MD, University of Alexandria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anna Abou-Raya, Professor of Rheumatology, University of Alexandria
• ClinicalTrials.gov Identifier: NCT01425827
• Other Study ID Numbers: alexmed116619163
• First Posted: Aug 30, 2011
• Last Update Posted: Aug 30, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Anna Abou-Raya, Professor of Rheumatology, University of Alexandria: duloxetine; osteoarthritis; pain; function
• Additional relevant MeSH terms: Osteoarthritis; Duloxetine Hydrochloride

Study Results

No Results Posted as of Aug 30, 2011