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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425827
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):
Anna Abou-Raya, Faculty of Medicine, University of Alexandria

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : November 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • primary knee osteoarthritis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01425827

Faculty of Medicine, University of Alexandria
Alexandria, Egypt, 00203
Sponsors and Collaborators
Faculty of Medicine, University of Alexandria
Principal Investigator: Anna Abou-Raya, MD Faculty of Medicine, University of Alexandria

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anna Abou-Raya, Professor of Rheumatology, Faculty of Medicine, University of Alexandria Identifier: NCT01425827     History of Changes
Other Study ID Numbers: alexmed116619163
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by Anna Abou-Raya, Faculty of Medicine, University of Alexandria:

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents