Overview

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

Status:
Not yet recruiting
Trial end date:
2024-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GrĂ¼nenthal GmbH
Criteria
Inclusion Criteria:

- The participant has given written informed consent to participate.

- The participant is 18 years of age or older at the Screening Visit.

- The participant has a diagnosis of osteoarthritis of the knee based on American
College of Rheumatology criteria and functional capacity class of I to III.

- There is a documented history indicating that participant has insufficient pain relief
with previous Standard of Care.

Exclusion Criteria:

- The participant has past joint replacement surgery of the index knee.

- The participant has a history of significant trauma or surgery (e.g., open or
arthroscopic) to the index knee within 12 months of Screening.

- The participant has periarticular pain from any cause other than osteoarthritis,
including referred pain, bursitis, or tendonitis.

- The participant has clinical hip osteoarthritis on the side of the index knee.

- The participant has pre-existing osteonecrosis, subchondral insufficiency fracture,
atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to
disease other than osteoarthritis, or the participant has rapidly progressing
osteoarthritis (RPOA) Type I or Type II.

- The participant has significant malalignment of anatomical axis (medial angle formed
by the femur and tibia) of the target knee (varus >10, valgus >10) by X-ray as
assessed by independent Central Readers at Screening Visit.

- The participant has other conditions that could affect trial endpoint assessments of
the index knee.

- The participant has current 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 participant's participation in the full
duration of the trial.

- The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any
similar component (capsaicin, chili peppers).

- The participant is currently participating or was participating in another
investigational drug trial within 3 months prior to the Screening Visit.

- The participant is an employee of the investigator or trial site, with direct
involvement in the proposed trial or other trials under the direction of that
investigator or trial site or is a family member of the employees or the investigator.