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

February 26, 2026 updated by: Grünenthal GmbH

A Randomized, Double-blind, Placebo-controlled, Phase III Trial, to Evaluate the Efficacy and Safety of a Single Intra-articular Injection of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial comprises a total observation period of up to 52 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
466

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Amager, Denmark, 2650
        • Arthroscopic Center, Copenhagen University Hospital
      • Frederiksberg, Denmark, 2000
        • The Parker Institute-Frederiksberg Hospital
  • Portugal
      • Alcabideche, Portugal, 2755-009
        • Hospital de Cascais
      • Lisbon, Portugal, 1500-458
        • Hospital Dos Lusiadas Lisboa
      • Porto, Portugal, 4100-180
        • Hospital CUF Porto
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Barcelona, Spain, 08034
        • Hospital Sanitas CIMA
      • Elche, Spain, 03203
        • Hospital General Universitario de Elche
      • Elche, Spain, 7105
        • Hospital Universitaro De Elche
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28100
        • Accellacare Alcobendas
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen De La Arrixaca (Huva)
      • Sabadell, Spain, 08208
        • Consorci Corporació Sanitària Parc Taulí
      • Sabadell, Spain, 08208
        • Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
      • Santiago de Compostela, Spain, 15702
        • Clinica Gaias
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
      • Santiago de Compostela, Spain, 15706
        • Complexo Hospitalario Universitario de Santiago de Compostela
      • Seville, Spain, 41010
        • Hospital Quironsalud Infanta Luisa
  • United Kingdom
      • Birmingham, United Kingdom, B31 2AP
        • Royal Orthopaedic Hospital - Nhs Foundation Trust
      • Glasgow, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary - Greater Glasgow Health Board
      • Northwood, United Kingdom, HA6 2RN
        • Accellacare North London
      • Orpington, United Kingdom, BR5 3QG
        • Accellacare South London
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN18 9EZ
        • Accellacare-Northamptonshire
    • Powys
      • Oswestry, Powys, United Kingdom, SY10 7AG
        • Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
    • Arizona
      • Glendale, Arizona, United States, 85351
        • Arizona Arthritis and Rheumatology Associates (AARA) P.C
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
      • Tucson, Arizona, United States, 85712
        • Tucson Orthopaedic Research Center
    • California
      • Anaheim, California, United States, 92801
        • Orange County Research Institute
      • Cerritos, California, United States, 90703
        • Core Health Care Group
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research, Inc.
      • Santa Barbara, California, United States, 93108
        • Dr. Hans Richard Barthel, MD Office Of
      • Thousand Oaks, California, United States, 91360
        • Westlake Medical Research
      • Thousand Oaks, California, United States, 91360
        • Medvin Clinical Research
    • Florida
      • Miami, Florida, United States, 33155
        • Allied Biomedical Research Institute
      • Miami, Florida, United States, 33173
        • Well Pharma Medical Research, Corp.
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare LLC
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sarasota, Florida, United States, 34232
        • Gulfcoast Research Institute
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Better Health Clinical Research, Inc.
      • Newnan, Georgia, United States, 30265
        • Vista Clinical Research
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83713
        • Injury Care Research
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Institute Inc.
      • Hazel Crest, Illinois, United States, 60429
        • Chicago Medical Research, LLC
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Neuroscience Research Center, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • DelRicht Research
      • New Orleans, Louisiana, United States, 70124
        • LCMC Health Urgent Care - Lakeview
    • Michigan
      • Lansing, Michigan, United States, 48911
        • June DO,PC
      • Troy, Michigan, United States, 48085
        • Oakland Medical Research Center
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
      • North Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Hartsdale, New York, United States, 10530
        • Drug Trials America
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Accellacare Research of Charlotte
      • Charlotte, North Carolina, United States, 28211
        • Park Road Medical Clinic
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Medical Group
      • Raleigh, North Carolina, United States, 27609
        • Accellacare of Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Gastroenterology Associates of the Piedmont
      • Winston-Salem, North Carolina, United States, 27103
        • Accellacare Research of Winston Salem
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • University Orthopedics Center
      • Altoona, Pennsylvania, United States, 9421166
        • University Orthopedics Center
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Indiana, Pennsylvania, United States, 15701
        • Antria Inc.
      • Philadelphia, Pennsylvania, United States, 19152-3303
        • Arthritis Group
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
      • Windber, Pennsylvania, United States, 15963
        • Chan Soon-Shiong Medical Center at Windber
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • PCPMG Clinical Research Unit, LLC
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Knoxville, Tennessee, United States, 37912
        • Accellacare - Knoxville
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RTX-GRT7039
Participants will receive a intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
Drug: RTX-GRT7039
RTX-GRT7039 intra-articular injection.
Placebo Comparator: Placebo
Participants will receive a intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.
Drug: Placebo
Placebo matching RTX-GRT7039 intra-articular injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Least Squares Mean (Standard Error) [LS-mean (SE) ] Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 12
Time Frame: From Baseline up to Week 12
Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
From Baseline up to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26
Time Frame: From Baseline up to Week 26
Difference in mean change from baseline in WOMAC pain subscale score using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
From Baseline up to Week 26
LS-mean Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 and Week 26
Time Frame: From Baseline up to Week 12 and Week 26
Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 17 questions using an 11-point numeric rating scale (NRS, from 0 = no difficulty to 10 = extreme difficulty). The scores are averaged over the number of questions.
From Baseline up to Week 12 and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grünenthal GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KF7039-02
  • 2021-005020-38 (EudraCT Number)
  • U1111-1268-7267 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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