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RTX-GRT7039 Injection for Osteoarthritis

Phase 3
Waitlist Available
Research Sponsored by Grünenthal GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 52
Awards & highlights

Study Summary

This trial tests if a single injection of a new drug can reduce pain from knee osteoarthritis when other treatments fail.

Who is the study for?
Adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments can join. They must understand and agree to the trial's process. Excluded are those with severe joint damage, past knee surgery within a year, significant leg misalignment, other conditions affecting safety or results, recent participation in another drug trial, employees involved in the study, clinical hip osteoarthritis on the same side, or allergy to resiniferatoxin.Check my eligibility
What is being tested?
The trial is testing RTX-GRT7039 against a placebo for knee osteoarthritis pain relief. Participants will receive one injection and be randomly assigned to either the treatment or placebo group without knowing which they received (double-blind). The goal is to confirm if RTX-GRT7039 is effective and safe.See study design
What are the potential side effects?
While specific side effects of RTX-GRT7039 aren't listed here, similar treatments may cause temporary injection site reactions like pain or swelling. Allergic reactions could occur in those sensitive to components related to resiniferatoxin.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Erythrocyte Indices
Secondary outcome measures
Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RTX-GRT7039Experimental Treatment1 Intervention
Participants will receive a single intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.

Find a Location

Who is running the clinical trial?

Grünenthal GmbHLead Sponsor
97 Previous Clinical Trials
33,618 Total Patients Enrolled
12 Trials studying Osteoarthritis
8,808 Patients Enrolled for Osteoarthritis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05449132 — Phase 3
Osteoarthritis Research Study Groups: RTX-GRT7039, Placebo
Osteoarthritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05449132 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05449132 — Phase 3
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05449132 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the drug RTX-GRT7039 been authorized by the United States Food and Drug Administration?

"The safety of RTX-GRT7039 is assessed as a 3 due to the prior clinical data gathered in Phase 3 trials that demonstrate efficacy and back up its overall security."

Answered by AI

Are there a multitude of healthcare facilities running this investigation within the state?

"Presently, the trial is being administered from 25 separate clinics. These sites are spread across Cerritos, Santa Barbara and Miami in addition to 22 other locations. For participants' convenience, it is advisable that they select a clinic closest to them when enrolling as this will reduce travel costs."

Answered by AI

How many participants can this experiment accommodate?

"Grünenthal GmbH, the trial's sponsor, requires 450 participants that meet their study criteria to run it successfully. The clinical research will be conducted at Tucson Orthopaedic Research Center in Cerritos, California and Core Health Care Group located in Santa Barbara, Florida."

Answered by AI

Is this trial currently accepting new participants?

"Affirmative. Clinicaltrials.gov presents evidence that this clinical trial is looking for volunteers, with the original posting date on August 26th 2022 and a recent update on February 23rd 2023. 450 individuals are desired across 25 sites."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Well Pharma Medical Research, Corp.
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Chicago Clinical Research Institute Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I need relief. Seeking alternative and more effective treatment for knees.
PatientReceived 1 prior treatment
I have osteoarthritis in my right knee and over the counter medication has not worked and.
PatientReceived 1 prior treatment
I've tried physical therapy, cortisone shots and hyaluronic acid I would love to walk without pain.
PatientReceived no prior treatments
~174 spots leftby Apr 2025