Phase 3 Osteoarthritis Trial, Recruiting NCT06497140 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Osteoarthritis
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Phase 3 Osteoarthritis Trial, Recruiting

NCT06497140
Recruiting Phase 3

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 who have been diagnosed with primary knee osteoarthritis according to standard medical guidelines set by the American College of Rheumatology
  • People whose knee X-rays show osteoarthritis rated at a score of 2 or higher on a standard scale (called the Kellgren and Lawrence scale)
  • People who have knee pain rated at 40 or more out of 100 on a pain measurement scale
  • People who have previously had an injection directly into the affected knee joint
  • People whose treating doctor has determined they are not suitable candidates for knee surgery
  • Women who could potentially become pregnant must have a negative pregnancy test before entering the trial
  • People who are affiliated with the French social security system
  • People who have signed a form giving their informed consent to participate
  • People who have a good understanding of the French language

Who may not be able to join:

  • People who have had any injection into the affected knee joint within the 3 months before the procedure
  • People who have previously had knee surgery, other than surgery to repair ligaments
  • People who have any inflammatory joint disease other than osteoarthritis (such as rheumatoid arthritis)
  • People for whom a puncture into a specific artery in the upper leg on the same side as the affected knee is not considered safe (confirm with trial site)
  • People currently taking certain medications, including cyclosporine, tacrolimus, cisplatin, vancomycin, amphotericin B, or a group of antibiotics called aminoglycosides
  • People who have painful hip osteoarthritis on the same side as the affected knee
  • People being treated for an overactive thyroid
  • People with a known severe allergy to a specific contrast dye called Lipiodol® or to iodine-based contrast dyes used in medical imaging
  • People with known moderate to severe kidney problems (based on a specific kidney function measurement) (confirm with trial site for exact threshold)
  • People with a known abnormal connection between the right and left sides of the heart, or an abnormal blood vessel connection within a tumour
  • People who have had an asthma attack in the 8 days before entering the trial
  • People who have a medical procedure or treatment using radioactive iodine planned within 1 month after entering the trial
  • People who have a symptomatic build-up of fatty deposits in the blood vessels of the same leg as the affected knee
  • People who are unable or unwilling to attend all required follow-up appointments, as determined by the trial investigator
  • Vulnerable individuals, including pregnant or breastfeeding women, people under legal guardianship or guardianship orders, or people who are not free to make their own decisions
  • People who are currently participating in another clinical trial and are still within that trial's exclusion period
  • People receiving French state medical aid (AME)

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 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Marc SAPOVAL, MD, Assistance Publique - Hôpitaux de Paris

Phone: 0140271848

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 3
Registry
ClinicalTrials.gov
Start date
30 September 2024
Est. completion
1 January 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Change of pain assessed by a Visual Analogue Scale (VAS) at 3 months compared to randomization.

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: 22 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