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A randomized, double-blind, placebo-controlled, Phase III trial to evaluate the efficacy and safety of intra-articular injections of RTX-GRT7039 in adult subjects with pain associated with osteoarthritis of the knee.

Comparison of RTX-GRT7039 and placebo injections for pain associated with osteoarthritis of the knee.

Lange Bernd, MD, MSc, Medical Lead

Grunenthal GmbH

4-1-3 Kyuutaromachi, Chuo-ku, Osaka

Japan-Chiken@iconplc.com

Clinical trial contact

ICON Clinical Research GK

4-1-3 Kyuutaromachi, Chuo-ku, Osaka

+81-6-4560-2001

Japan-Chiken@iconplc.com

Not Recruiting

Oct. 01, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- >=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 severe osteoarthritis at baseline.
- 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.

- The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within 3 months.
-The subject had an injection of platelet-rich plasma into the index knee within 6 months.
- The subject applied topical capsaicin on the index knee within 3 months.
- 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.

Both

Moderate to severe pain associated with osteoarthritis of the knee

RTX-GRT7039 intra-articular injection.

1) Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score in the index knee.

1) Change in WOMAC pain subscale score in the index knee based on the 11-point numeric rating scale (NRS).
2) Change in WOMAC physical function subscale score.
3) Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to treatment discontinuation after the first injection.
Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI]).

+81-42-648-5551

June. 17, 2022

No

Canada/Czech Republic/France/Germany/Italy/Mexico/Netherland/Poland