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OsteoarthritisPhase 3NCT05449132

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

A Phase 3 study testing RTX-GRT7039 in people with Osteoarthritis, run by Grünenthal GmbH at 81 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
RTX-GRT7039
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
466 participants
Where
81 sitesin 5 countries
Study dates
26 Sep 2022to 15 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

81 sites in 5 countries.

81 sites in 5 countries

United States56 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • University Orthopedics Center

    Altoona, Pennsylvania, 16602

  • University Orthopedics Center

    Altoona, Pennsylvania, 9421166

  • Orange County Research Institute

    Anaheim, California, 92801

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Injury Care Research

    Boise, Idaho, 83713

  • Core Health Care Group

    Cerritos, California, 90703

  • Accellacare Research of Charlotte

    Charlotte, North Carolina, 28209

  • Park Road Medical Clinic

    Charlotte, North Carolina, 28211

  • Charlottesville Medical Research Center LLC

    Charlottesville, Virginia, 22911

  • Chicago Clinical Research Institute Inc.

    Chicago, Illinois, 60607

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Arizona Arthritis and Rheumatology Associates (AARA) P.C

    Glendale, Arizona, 85351

  • PCPMG Clinical Research Unit, LLC

    Greenville, South Carolina, 29601

  • Drug Trials America

    Hartsdale, New York, 10530

  • Chicago Medical Research, LLC

    Hazel Crest, Illinois, 60429

  • Antria Inc.

    Indiana, Pennsylvania, 15701

  • Accellacare - Knoxville

    Knoxville, Tennessee, 37912

  • June DO,PC

    Lansing, Michigan, 48911

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • Well Pharma Medical Research, Corp.

    Miami, Florida, 33173

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • LCMC Health Urgent Care - Lakeview

    New Orleans, Louisiana, 70124

  • Better Health Clinical Research, Inc.

    Newnan, Georgia, 30265

  • Vista Clinical Research

    Newnan, Georgia, 30265

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada, 89030

  • Sensible Healthcare LLC

    Ocoee, Florida, 34761

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Orlando, Florida, 32801

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Neuroscience Research Center, LLC

    Overland Park, Kansas, 66210

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152-3303

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Accellacare of Raleigh

    Raleigh, North Carolina, 27609

  • Raleigh Medical Group

    Raleigh, North Carolina, 27609

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Acclaim Clinical Research, Inc.

    San Diego, California, 92120

  • Dr. Hans Richard Barthel, MD Office Of

    Santa Barbara, California, 93108

  • Gulfcoast Research Institute

    Sarasota, Florida, 34232

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • University Orthopedics Center

    State College, Pennsylvania, 16801

  • Medvin Clinical Research

    Thousand Oaks, California, 91360

  • Westlake Medical Research

    Thousand Oaks, California, 91360

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Tucson Orthopaedic Research Center

    Tucson, Arizona, 85712

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • Chan Soon-Shiong Medical Center at Windber

    Windber, Pennsylvania, 15963

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina, 27103

  • Gastroenterology Associates of the Piedmont

    Winston-Salem, North Carolina, 27103

  • The Center For Clinical Research

    Winston-Salem, North Carolina, 27103

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

Spain14 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital Sanitas Cima

    Barcelona, 08034

  • Hospital General Universitario de Elche

    Elche, 03203

  • Hospital Universitaro De Elche

    Elche, 7105

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Accellacare Alcobendas

    Madrid, 28100

  • Hospital Universitario Virgen De La Arrixaca (Huva)

    Murcia, 30120

  • Consorci Corporacio Sanitaria Parc Tauli

    Sabadell, 08208

  • Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli

    Sabadell, 08208

  • Clinica Gaias

    Santiago de Compostela, 15702

  • Complexo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

  • Hospital Clinico Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

Other trials in Spain

United Kingdom6 sites

  • Royal Orthopaedic Hospital - Nhs Foundation Trust

    Birmingham, B31 2AP

  • Accellacare-Northamptonshire

    Corby, Northamptonshire, NN18 9EZ

  • Glasgow Royal Infirmary - Greater Glasgow Health Board

    Glasgow, G4 0SF

  • Accellacare North London

    Northwood, HA6 2RN

  • Accellacare South London

    Orpington, BR5 3QG

  • Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

    Oswestry, Powys, SY10 7AG

Other trials in United Kingdom

Portugal3 sites

  • Hospital de Cascais

    Alcabideche, 2755-009

  • Hospital Dos Lusiadas Lisboa

    Lisbon, 1500-458

  • Hospital CUF Porto

    Porto, 4100-180

Other trials in Portugal

Denmark2 sites

  • Arthroscopic Center, Copenhagen University Hospital

    Amager, 2650

  • The Parker Institute-Frederiksberg Hospital

    Frederiksberg, 2000

Other trials in Denmark

About this study

Official title: 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.

Read the detailed description

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

Conditions
Osteoarthritis
Being tested
RTX-GRT7039, Placebo
Keywords
Knee, Osteoarthritis, Pain assessment
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTX-GRT7039Drug

    RTX-GRT7039 intra-articular injection.

  • PlaceboDrug

    Placebo matching RTX-GRT7039 intra-articular injection.

Study groups in NCT05449132
Study groupRoleWhat they receive
RTX-GRT7039ExperimentalParticipants will receive a intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
Receives: Drug: RTX-GRT7039
PlaceboPlacebo comparatorParticipants will receive a intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: From Baseline up to Week 12

Secondary outcomes (2)

  1. LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at 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.

    Measured: From Baseline up to Week 26

  2. LS-mean Change From Baseline in WOMAC Physical Function Subscale Score at 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.

    Measured: From Baseline up to Week 12 and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start26 Sep 2022
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05449132
Sponsor's protocol ID
KF7039-02
Other IDs
2021-005020-38, U1111-1268-7267
Status last verified
Feb 2026
First submitted
4 Jul 2022
Last updated
18 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RTX-GRT7039 in people with Osteoarthritis, run by Grünenthal GmbH at 81 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Spain, United Kingdom, Portugal, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05449132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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