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RTX-GRT7039 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
There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 52
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new injectable drug for knee pain caused by osteoarthritis.

Who is the study for?
Adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments can join. They must meet specific criteria for the severity of their condition and not have other knee issues or sensitivities to components like capsaicin. Recent surgery, significant trauma, or participation in another drug trial disqualifies them.Check my eligibility
What is being tested?
The trial is testing RTX-GRT7039 against a placebo in patients with knee osteoarthritis pain. Participants will receive repeated injections to see if it's effective and safe compared to no active treatment. The study randomly assigns participants to either the test drug or placebo group without them knowing which one they're getting.See study design
What are the potential side effects?
While the potential side effects are not listed here, similar compounds like capsaicin may cause local reactions such as burning or stinging at the injection site, increased knee pain, swelling, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have tried the standard treatment for your pain before, but it didn't work well enough for you.

Timeline

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
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
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
Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RTX-GRT7039Experimental Treatment1 Intervention
Participants will receive 2 intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive 2 intra-articular injections of placebo matching to 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: NCT05248386 — Phase 3
Osteoarthritis Research Study Groups: RTX-GRT7039, Placebo
Osteoarthritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05248386 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05248386 — Phase 3

Frequently Asked Questions

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

Are there any open opportunities for volunteers to join this clinical research?

"Confirmed, this medical trial is still recruiting participants. Clinicaltrials.gov states the study's initial posting was on August 26th 2022 and the last update was February 23rd 2023."

Answered by AI

How likely are adverse effects for those taking RTX-GRT7039?

"Our team at Power evaluated RTX-GRT7039's safety as a 3, given that there are sufficient clinical trials to demonstrate its efficacy and multiple studies showing it is safe."

Answered by AI

How many medical institutions are offering this research experiment?

"Currently, Aggarwal and Associates Limited in Brampton, Malton Medical Research in Mississauga, Diex Research Sherbrooke Inc. in Sherbrooke are all participating sites for this ongoing trial with an additional 4 locations also actively recruiting patients."

Answered by AI

How many participants have been recruited for this research endeavor?

"To properly conduct this clinical trial, an aggregate total of 450 qualified individuals must be enrolled. Patients are able to participate from two sites in the provinces of Ontario and Quebec; Aggarwal and Associates Limited located in Brampton and Malton Medical Research situated in Mississauga."

Answered by AI
~174 spots leftby Mar 2025