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.
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 |
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 |
This trial comprises a total observation period of up to 52 weeks.
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.
Drug: - RTX-GRT7039
RTX-GRT7039 intra-articular injection.
Drug: - Placebo
Placebo matching RTX-GRT7039 intra-articular injection.
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.
Status
Recruiting
Address
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Status
Recruiting
Address
Arizona Arthritis and Rheumatology Associates (AARA) P.C
Glendale, Arizona, 85351
Status
Recruiting
Address
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
Status
Recruiting
Address
Noble Clinical Research
Tucson, Arizona, 85704
Status
Recruiting
Address
Tucson Orthopaedic Research Center
Tucson, Arizona, 85712
Status
Recruiting
Address
Orange County Research Institute
Anaheim, California, 92801
Status
Recruiting
Address
Core Health Care Group
Cerritos, California, 90703
Status
Not yet recruiting
Address
Dream Team Clinical Research
Pomona, California, 91767
Status
Recruiting
Address
Acclaim Clinical Research, Inc.
San Diego, California, 92120
Status
Recruiting
Address
Dr. Hans Richard Barthel, MD Office Of
Santa Barbara, California, 93108
Status
Completed
Address
Medvin Clinical Research
Thousand Oaks, California, 91360
Status
Recruiting
Address
Allied Biomedical Research Institute
Miami, Florida, 33155
Status
Recruiting
Address
Well Pharma Medical Research, Corp.
Miami, Florida, 33173
Status
Recruiting
Address
Sensible Healthcare LLC
Ocoee, Florida, 34761
Status
Recruiting
Address
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, Florida, 32801
Status
Recruiting
Address
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Status
Recruiting
Address
Progressive Medical Research
Port Orange, Florida, 32127
Status
Recruiting
Address
Gulfcoast Research Institute
Sarasota, Florida, 34232
Status
Recruiting
Address
Horizon Clinical Research
Newnan, Georgia, 30265
Status
Recruiting
Address
North Georgia Clinical Research
Woodstock, Georgia, 30189
Status
Recruiting
Address
Injury Care Research
Boise, Idaho, 83713
Status
Recruiting
Address
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60607
Status
Recruiting
Address
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Status
Recruiting
Address
Neuroscience Research Center, LLC
Overland Park, Kansas, 66210
Status
Recruiting
Address
LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana, 70124
Status
Completed
Address
June DO,PC
Lansing, Michigan, 48911
Status
Recruiting
Address
Oakland Medical Research Center
Troy, Michigan, 48085
Status
Recruiting
Address
Sundance Clinical Research, LLC
Saint Louis, Missouri, 63141
Status
Recruiting
Address
Excel Clinical Research
Las Vegas, Nevada, 89109
Status
Recruiting
Address
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030
Status
Recruiting
Address
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Status
Recruiting
Address
Drug Trials America
Hartsdale, New York, 10530
Status
Recruiting
Address
Upstate Clinical Research Associates
Williamsville, New York, 14221
Status
Recruiting
Address
Park Road Medical Clinic
Charlotte, North Carolina, 28211
Status
Recruiting
Address
Accellacare of Raleigh
Raleigh, North Carolina, 27609
Status
Recruiting
Address
Accellacare Research of Winston Salem
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
The Center For Clinical Research
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
University Orthopedics Center
Altoona, Pennsylvania, 16602
Status
Recruiting
Address
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Status
Recruiting
Address
Arthritis Group
Philadelphia, Pennsylvania, 19152-3303
Status
Recruiting
Address
University Orthopedics Center
State College, Pennsylvania, 16801
Status
Recruiting
Address
Chan Soon-Shiong Medical Center at Windber
Windber, Pennsylvania, 15963
Status
Recruiting
Address
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601
Status
Recruiting
Address
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Status
Recruiting
Address
Health Concepts
Rapid City, South Dakota, 57702
Status
Recruiting
Address
Accellacare - Knoxville
Knoxville, Tennessee, 37912
Status
Recruiting
Address
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Status
Recruiting
Address
Charlottesville Medical Research Center LLC
Charlottesville, Virginia, 22911
Status
Recruiting
Address
Arthroscopic Center, Copenhagen University Hospital
Amager-Hvidovre, , 2650
Status
Recruiting
Address
The Parker Institute-Frederiksberg Hospital
Frederiksberg, , 2000
Status
Recruiting
Address
Hospital de Cascais
Alcabideche, , 2755-009
Status
Recruiting
Address
Hospital Dos Lusiadas Lisboa
Lisboa, , 1500-458
Status
Recruiting
Address
Hospital CUF Porto
Porto, , 4100-180
Status
Recruiting
Address
Complejo Hospitalario Universitario A Coruna
A Coruña, , 15006
Status
Recruiting
Address
Hospital Sanitas Cima
Barcelona, , 08034
Status
Recruiting
Address
Hospital General Universitario de Elche
Elche, , 03203
Status
Recruiting
Address
Hospital Universitario Virgen de las Nieves
Granada, , 18014
Status
Recruiting
Address
Hospital Universitario de La Princesa
Madrid, , 28006
Status
Recruiting
Address
Accellacare Alcobendas
Madrid, , 28100
Status
Recruiting
Address
Hospital Universitario Virgen De La Arrixaca (Huva)
Murcia, , 30120
Status
Recruiting
Address
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
Sabadell, , 08208
Status
Recruiting
Address
Clinica Gaias
Santiago de Compostela, , 15702
Status
Recruiting
Address
Hospital Clinico Universitario De Santiago De Compostela
Santiago De Compostela, , 15706
Status
Recruiting
Address
Hospital Quironsalud Infanta Luisa
Sevilla, , 41010
Status
Recruiting
Address
Accellacare-Northamptonshire
Corby, Northamptonshire, NN18 9EZ
Status
Recruiting
Address
Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Powys, SY10 7AG
Status
Recruiting
Address
Glasgow Royal Infirmary - Greater Glasgow Health Board
Glasgow, , G4 0SF
Status
Recruiting
Address
Royal Orthopaedic Hospital - Nhs Foundation Trust
Northfield Birminham, , B31 2AP
Status
Recruiting
Address
Accellacare North London
Northwood, , HA6 2RN
Status
Recruiting
Address
Accellacare South London
Orpington, , BR5 3QG