ACTRN12619001082190
Recruiting
Phase 3
Venlafaxine compared to duloxetine for the treatment of osteoarthritis pain: A double-blind, randomised, non-inferiority trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Knee osteoarthritis
- Sponsor
- Waitemata District Health Board
- Enrollment
- 146
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females at least 40 years old who have radiographic evidence of knee osteoarthritis and meet the American College of Rheumatology clinical criteria for the diagnosis of knee osteoarthritis.
- •A history of knee pain for \> 14 days days of each month for 3 months or more.
- •A brief pain inventory average pain rating of at least 4/10 at the time of initial screening
Exclusion Criteria
- •Current use of antidepressant medication or any other medication with a serotonergic effect; use of a MAOI inhibitor in the last 14 days; narrow\-angle glaucoma; BMI \> or \= to 40; diagnosis of any other type of arthritis; joint injection or surgery on the index knee within the last 3 months; impending surgery in the next 3 months; medical contraindication to the use of rescue medications (acetaminophen and NSAIDs); patients taking any excluded medications that cannot be discontinued; women who are pregnant, breast feeding or planning to get pregnant; previous diagnosis of a major psychiatric disorder; history of alcoholism; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 100 IU/L or total bilirubin \> 27\.4 umol/L; glomerular filtration rate of \< 30ml/min; a history of myocardial infarction in the last 12 months, QTc interval \> 500ms, unstable coronary artery disease or recent unexplained cardiac symptoms; uncontrolled hypertension (\> or \= to 140mmHg systolic or \> or \= to 90mmHg diastolic BP); a history of seizures; a history of multiple falls in the last 12 months; current use of warfarin; an inability to perform psychophysical testing.
Outcomes
Primary Outcomes
Not specified
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