NCT05377489

Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee

A Single-arm, Open-label, Phase III Trial to Evaluate the Safety and Tolerability of Intra-articular Injections of RTX-GRT7039 in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 714 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Detailed description

This trial comprises a total observation period of up to 78 weeks.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	RTX-GRT7039	RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-05-15
• Completion: 2025-05-15
• First posted: 2022-05-17
• Last updated: 2026-03-12
• Results posted: 2025-11-28

Locations

96 sites across 7 countries: United States, Bulgaria, Japan, Poland, Romania, South Africa, United Kingdom

Regulatory

• FDA-regulated drug study