Serotonin Noradrenaline Reuptake Inhibitors (SNRI) medications for the treatment of osteoarthritis pain (STOP) trial

Phase 3

Recruiting

• Conditions: Knee osteoarthritis; Anaesthesiology - Pain management; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12619001082190
• Lead Sponsor: Waitemata District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-06
• Last Update Posted: 28 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 146

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Brief Pain Inventory average pain rating.[Weekly from baseline to end of week 9.]