Open-label trial to check the safety and tolerability of RTX-GRT7039 injections for pain associated with osteoarthritis of the knee.

Phase 3

Recruiting

• Conditions: Moderate to severe pain associated with osteoarthritis of the knee

• Registration Number: JPRN-jRCT2031230069
• Lead Sponsor: ange Bernd, MD, MSc, Medical Lead

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

>=18 years of age at the screening visit.
- Body Mass Index (BMI)=< 40.0 kg/m2.
- Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I-III.
- Moderate to severepain due to osteoarthritis of the knee.
- Documented history indicating that subject has insufficient pain relief with optimal standard of care (SoC).
- The investigator does not consider that any additional benefit can reasonably be expected from further adjustments to the patient's pain treatment.

Exclusion Criteria

- The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within one month.
- The subject had an injection of platelet-rich plasma into the index knee within one month.
- The subject applied topical capsaicin on the index knee within 3months.
- Pre-existing rapidly progressing osteoarthritis (RPOA) Type I or Type II, osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, or the subject has knee pain attributable to disease other than osteoarthritis.
- Other conditions that could confound discrimination of pain assessment in the index knee.
- Clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's
opinion, may preclude the subject's participation in the full duration of the trial.
- History of severe allergic or anaphylactic reactions.
- History of significant trauma or surgery, or surgery planned during the trial period, related to the knee.

Study & Design

• Study Type: Interventional
• Study Design: Not specified