NCT05449132

Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee

A Randomized, Double-blind, Placebo-controlled, Phase III Trial, to Evaluate the Efficacy and Safety of a Single Intra-articular Injection of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of single injection of RTX-GRT7039 versus placebo 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 52 weeks.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	RTX-GRT7039	RTX-GRT7039 intra-articular injection.
DRUG	Placebo	Placebo matching RTX-GRT7039 intra-articular injection.

Timeline

• Start date: 2022-09-26
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2022-07-08
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

81 sites across 5 countries: United States, Denmark, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study