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

NCT05449132 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2026-03-18

Study results available
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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.

Conditions

Interventions

DRUG

RTX-GRT7039

RTX-GRT7039 intra-articular injection.

DRUG

Placebo

Placebo matching RTX-GRT7039 intra-articular injection.

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2024-08-15
Completion
2024-08-15
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449132 on ClinicalTrials.gov