Phase 4 Osteoarthritis Trial, Recruiting NCT06423716 Sponsor: Sunnybrook Health Sciences Centre Condition: Osteoarthritis
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Phase 4 Osteoarthritis Trial, Recruiting

NCT06423716
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 50 or older
  • People who have been diagnosed with knee osteoarthritis
  • People who are scheduled for a planned, non-emergency knee replacement surgery on one knee
  • People whose overall health status falls within a certain acceptable range for surgery (confirm with trial site)
  • People with adequate kidney function — either confirmed by a blood test taken within the past 60 days, or who report having no known kidney disease

Who may not be able to join:

  • People who do not wish to give consent, or who are unlikely to attend follow-up appointments
  • People who have a known allergy or sensitivity to the study drug or its ingredients
  • People with a known liver disease, such as cirrhosis or non-alcoholic steatohepatitis
  • People with uncontrolled narrow-angle glaucoma
  • People with severe kidney impairment (confirmed by kidney function testing)
  • People currently taking a medication called thioridazine
  • People currently taking certain medications that strongly affect how the body processes drugs, including fluvoxamine or certain antibiotics such as ciprofloxacin or enoxacin
  • People currently taking antidepressants, including MAOIs, SSRIs, SNRIs, tricyclic antidepressants, St. John's Wort, or buspirone
  • People currently taking triptan medications (often used for migraines) or lithium
  • People taking high doses of opioid pain medications (above a certain daily threshold — confirm with trial site)
  • People with a substance use disorder, including issues related to cannabis, alcohol, opioids, or illicit drugs
  • People with uncontrolled high blood pressure above a certain level
  • People with an untreated mental health condition, such as depression, suicidal thoughts, or bipolar disorder
  • People who are currently involved in a workers' compensation claim or legal case related to their condition

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 416-480-4864

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 November 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Opioid consumption

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov