Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 52
Awards & highlights
Pivotal Trial
Summary
This trial tests a special injection called RTX-GRT7039 to help reduce knee pain in people with osteoarthritis who still have pain despite usual treatments. The injection works by blocking pain signals from the knee.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Erythrocyte Indices
Secondary study objectives
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
Pain
+9 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RTX-GRT7039Experimental Treatment1 Intervention
Participants will receive a intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RTX-GRT7039
2022
Completed Phase 3
~450
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for osteoarthritis (OA) focus on pain relief and reducing inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing prostaglandin production and thus inflammation and pain.
Intra-articular injections, such as corticosteroids, provide localized anti-inflammatory effects, while investigational treatments like platelet-rich plasma (PRP) aim to reduce inflammation and promote tissue repair through growth factors. Gene therapies, such as those involving TGF-beta, target cellular pathways to maintain cartilage and reduce joint degradation.
Understanding these mechanisms helps OA patients and their doctors choose treatments that best address pain and inflammation, improving quality of life.
Pathophysiology and first-line treatment of osteoarthritis.
Pathophysiology and first-line treatment of osteoarthritis.
Find a Location
Who is running the clinical trial?
Grünenthal GmbHLead Sponsor
98 Previous Clinical Trials
33,738 Total Patients Enrolled
13 Trials studying Osteoarthritis
8,928 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried the usual treatments for your pain, but they did not work well enough for you.You have certain existing bone conditions or severe knee pain that is not caused by osteoarthritis.You have hip osteoarthritis on the same side as your knee condition.You have pain near a joint, but it's not caused by osteoarthritis or other common conditions like bursitis or tendonitis.You have other health conditions that may affect the evaluation of your knee during the trial.You have had an allergic reaction to resiniferatoxin (RTX) or similar substances found in capsaicin or chili peppers.
Research Study Groups:
This trial has the following groups:- Group 1: RTX-GRT7039
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05449132 — Phase 3