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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05449132
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Grünenthal GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Denmark, Portugal, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis
Additional Details

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

Arms & Interventions

Arms

Experimental: RTX-GRT7039

Participants will receive a single intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.

Placebo Comparator: Placebo

Participants will receive a single intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.

Interventions

Drug: - RTX-GRT7039

RTX-GRT7039 intra-articular injection.

Drug: - Placebo

Placebo matching RTX-GRT7039 intra-articular injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Achieve Clinical Research, LLC, Birmingham, Alabama

Status

Recruiting

Address

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216

Glendale, Arizona

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Associates (AARA) P.C

Glendale, Arizona, 85351

Elite Clinical Studies, LLC, Phoenix, Arizona

Status

Recruiting

Address

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018

Noble Clinical Research, Tucson, Arizona

Status

Recruiting

Address

Noble Clinical Research

Tucson, Arizona, 85704

Tucson Orthopaedic Research Center, Tucson, Arizona

Status

Recruiting

Address

Tucson Orthopaedic Research Center

Tucson, Arizona, 85712

Orange County Research Institute, Anaheim, California

Status

Recruiting

Address

Orange County Research Institute

Anaheim, California, 92801

Core Health Care Group, Cerritos, California

Status

Recruiting

Address

Core Health Care Group

Cerritos, California, 90703

Dream Team Clinical Research, Pomona, California

Status

Not yet recruiting

Address

Dream Team Clinical Research

Pomona, California, 91767

Acclaim Clinical Research, Inc., San Diego, California

Status

Recruiting

Address

Acclaim Clinical Research, Inc.

San Diego, California, 92120

Dr. Hans Richard Barthel, MD Office Of, Santa Barbara, California

Status

Recruiting

Address

Dr. Hans Richard Barthel, MD Office Of

Santa Barbara, California, 93108

Medvin Clinical Research, Thousand Oaks, California

Status

Completed

Address

Medvin Clinical Research

Thousand Oaks, California, 91360

Allied Biomedical Research Institute, Miami, Florida

Status

Recruiting

Address

Allied Biomedical Research Institute

Miami, Florida, 33155

Well Pharma Medical Research, Corp., Miami, Florida

Status

Recruiting

Address

Well Pharma Medical Research, Corp.

Miami, Florida, 33173

Sensible Healthcare LLC, Ocoee, Florida

Status

Recruiting

Address

Sensible Healthcare LLC

Ocoee, Florida, 34761

Orlando, Florida

Status

Recruiting

Address

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Orlando, Florida, 32801

Clinical Neuroscience Solutions, Inc., Orlando, Florida

Status

Recruiting

Address

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806

Progressive Medical Research, Port Orange, Florida

Status

Recruiting

Address

Progressive Medical Research

Port Orange, Florida, 32127

Gulfcoast Research Institute, Sarasota, Florida

Status

Recruiting

Address

Gulfcoast Research Institute

Sarasota, Florida, 34232

Horizon Clinical Research, Newnan, Georgia

Status

Recruiting

Address

Horizon Clinical Research

Newnan, Georgia, 30265

North Georgia Clinical Research, Woodstock, Georgia

Status

Recruiting

Address

North Georgia Clinical Research

Woodstock, Georgia, 30189

Injury Care Research, Boise, Idaho

Status

Recruiting

Address

Injury Care Research

Boise, Idaho, 83713

Chicago Clinical Research Institute Inc., Chicago, Illinois

Status

Recruiting

Address

Chicago Clinical Research Institute Inc.

Chicago, Illinois, 60607

MediSphere Medical Research Center, LLC, Evansville, Indiana

Status

Recruiting

Address

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714

Neuroscience Research Center, LLC, Overland Park, Kansas

Status

Recruiting

Address

Neuroscience Research Center, LLC

Overland Park, Kansas, 66210

LCMC Health Urgent Care - Lakeview, New Orleans, Louisiana

Status

Recruiting

Address

LCMC Health Urgent Care - Lakeview

New Orleans, Louisiana, 70124

June DO,PC, Lansing, Michigan

Status

Completed

Address

June DO,PC

Lansing, Michigan, 48911

Oakland Medical Research Center, Troy, Michigan

Status

Recruiting

Address

Oakland Medical Research Center

Troy, Michigan, 48085

Sundance Clinical Research, LLC, Saint Louis, Missouri

Status

Recruiting

Address

Sundance Clinical Research, LLC

Saint Louis, Missouri, 63141

Excel Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

Excel Clinical Research

Las Vegas, Nevada, 89109

Las Vegas Clinical Trials, LLC, North Las Vegas, Nevada

Status

Recruiting

Address

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, 89030

Albuquerque Clinical Trials, Inc., Albuquerque, New Mexico

Status

Recruiting

Address

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102

Drug Trials America, Hartsdale, New York

Status

Recruiting

Address

Drug Trials America

Hartsdale, New York, 10530

Upstate Clinical Research Associates, Williamsville, New York

Status

Recruiting

Address

Upstate Clinical Research Associates

Williamsville, New York, 14221

Park Road Medical Clinic, Charlotte, North Carolina

Status

Recruiting

Address

Park Road Medical Clinic

Charlotte, North Carolina, 28211

Accellacare of Raleigh, Raleigh, North Carolina

Status

Recruiting

Address

Accellacare of Raleigh

Raleigh, North Carolina, 27609

Accellacare Research of Winston Salem, Winston-Salem, North Carolina

Status

Recruiting

Address

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, 27103

The Center For Clinical Research, Winston-Salem, North Carolina

Status

Recruiting

Address

The Center For Clinical Research

Winston-Salem, North Carolina, 27103

University Orthopedics Center, Altoona, Pennsylvania

Status

Recruiting

Address

University Orthopedics Center

Altoona, Pennsylvania, 16602

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

Arthritis Group, Philadelphia, Pennsylvania

Status

Recruiting

Address

Arthritis Group

Philadelphia, Pennsylvania, 19152-3303

University Orthopedics Center, State College, Pennsylvania

Status

Recruiting

Address

University Orthopedics Center

State College, Pennsylvania, 16801

Windber, Pennsylvania

Status

Recruiting

Address

Chan Soon-Shiong Medical Center at Windber

Windber, Pennsylvania, 15963

PCPMG Clinical Research Unit, LLC, Greenville, South Carolina

Status

Recruiting

Address

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601

Coastal Carolina Research Center, North Charleston, South Carolina

Status

Recruiting

Address

Coastal Carolina Research Center

North Charleston, South Carolina, 29405

Health Concepts, Rapid City, South Dakota

Status

Recruiting

Address

Health Concepts

Rapid City, South Dakota, 57702

Accellacare - Knoxville, Knoxville, Tennessee

Status

Recruiting

Address

Accellacare - Knoxville

Knoxville, Tennessee, 37912

Wasatch Clinical Research, Salt Lake City, Utah

Status

Recruiting

Address

Wasatch Clinical Research

Salt Lake City, Utah, 84107

Charlottesville, Virginia

Status

Recruiting

Address

Charlottesville Medical Research Center LLC

Charlottesville, Virginia, 22911

International Sites

Amager-Hvidovre, Denmark

Status

Recruiting

Address

Arthroscopic Center, Copenhagen University Hospital

Amager-Hvidovre, , 2650

Frederiksberg, Denmark

Status

Recruiting

Address

The Parker Institute-Frederiksberg Hospital

Frederiksberg, , 2000

Hospital de Cascais, Alcabideche, Portugal

Status

Recruiting

Address

Hospital de Cascais

Alcabideche, , 2755-009

Hospital Dos Lusiadas Lisboa, Lisboa, Portugal

Status

Recruiting

Address

Hospital Dos Lusiadas Lisboa

Lisboa, , 1500-458

Hospital CUF Porto, Porto, Portugal

Status

Recruiting

Address

Hospital CUF Porto

Porto, , 4100-180

A Coruña, Spain

Status

Recruiting

Address

Complejo Hospitalario Universitario A Coruna

A Coruña, , 15006

Hospital Sanitas Cima, Barcelona, Spain

Status

Recruiting

Address

Hospital Sanitas Cima

Barcelona, , 08034

Hospital General Universitario de Elche, Elche, Spain

Status

Recruiting

Address

Hospital General Universitario de Elche

Elche, , 03203

Granada, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de las Nieves

Granada, , 18014

Hospital Universitario de La Princesa, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de La Princesa

Madrid, , 28006

Accellacare Alcobendas, Madrid, Spain

Status

Recruiting

Address

Accellacare Alcobendas

Madrid, , 28100

Murcia, Spain

Status

Recruiting

Address

Hospital Universitario Virgen De La Arrixaca (Huva)

Murcia, , 30120

Sabadell, Spain

Status

Recruiting

Address

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

Sabadell, , 08208

Clinica Gaias, Santiago de Compostela, Spain

Status

Recruiting

Address

Clinica Gaias

Santiago de Compostela, , 15702

Santiago De Compostela, Spain

Status

Recruiting

Address

Hospital Clinico Universitario De Santiago De Compostela

Santiago De Compostela, , 15706

Hospital Quironsalud Infanta Luisa, Sevilla, Spain

Status

Recruiting

Address

Hospital Quironsalud Infanta Luisa

Sevilla, , 41010

Accellacare-Northamptonshire, Corby, Northamptonshire, United Kingdom

Status

Recruiting

Address

Accellacare-Northamptonshire

Corby, Northamptonshire, NN18 9EZ

Oswestry, Powys, United Kingdom

Status

Recruiting

Address

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

Oswestry, Powys, SY10 7AG

Glasgow, United Kingdom

Status

Recruiting

Address

Glasgow Royal Infirmary - Greater Glasgow Health Board

Glasgow, , G4 0SF

Northfield Birminham, United Kingdom

Status

Recruiting

Address

Royal Orthopaedic Hospital - Nhs Foundation Trust

Northfield Birminham, , B31 2AP

Accellacare North London, Northwood, United Kingdom

Status

Recruiting

Address

Accellacare North London

Northwood, , HA6 2RN

Accellacare South London, Orpington, United Kingdom

Status

Recruiting

Address

Accellacare South London

Orpington, , BR5 3QG