The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee osteoarthritis pain. Study details include:
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. |
NCT04809376 |
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 2/Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Paradigm Biopharmaceuticals USA (INC) |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Thomas Schnitzer |
Principal Investigator Affiliation | Northwestern University Feinberg School of Medicine |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Osteoarthritis, Knee |
This is a 2-stage, adaptive, randomized, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain. In Stage 1 (dose selection), approximately 468 participants will be randomised 1:1:1:1 to receive 1 of 3 PPS dose regimens or placebo for 6 weeks. A minimum of 96 participants (24 within each dose group) will be assigned to the Pharmacokinetic (PK) subset. Participants in Stage 1 will be randomly allocated to receive:
Experimental: PPS Twice Weekly
Pentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks
Experimental: PPS Once Weekly
Pentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks
Experimental: PPS Fixed Dose Once Weekly
Pentosan Polysulfate Sodium (PPS) Fixed dose (100mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks
Placebo Comparator: Placebo
Placebo twice weekly for 6 weeks
Drug: - Pentosan Polysulfate Sodium twice weekly
Subcutaneous Injection, 1.5mg/kg Ideal body Weight (IBW)
Drug: - Placebo (Sodium Chloride Injection, 0.9%)
Placebo to match PPS
Drug: - Pentosan Polysulfate Sodium Fixed Dose
Subcutaneous Injection, 100/150/180 mg if <65kg/ ≥ 65 kg and ≤ 90kg/ >90 kg IBW
Drug: - Pentosan Polysulfate Sodium once weekly
Subcutaneous Injection, 2.0mg/kg Ideal body Weight (IBW)
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
Not yet recruiting
Address
Alliance for Multispecialty Research - Tempe
Tempe, Arizona, 85281
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Address
Fiel Family and Sports Medicine
Tempe, Arizona, 85283
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Address
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
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Address
Core Healthcare Group
Cerritos, California, 90703
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Address
Biosolutions Clinical Research Center
La Mesa, California, 91942
Status
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Address
Providence Clinical Research
North Hollywood, California, 91606
Status
Not yet recruiting
Address
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
Status
Not yet recruiting
Address
Encompass Clinical Research
Spring Valley, California, 91978
Status
Not yet recruiting
Address
Clinical Research of West Florida- Clearwater
Clearwater, Florida, 33765
Status
Not yet recruiting
Address
University Clinical Research-Deland
DeLand, Florida, 32720
Status
Not yet recruiting
Address
LMG Research
Miami, Florida, 33125
Status
Recruiting
Address
Well Pharma Medical Research, Corp.
Miami, Florida, 33173
Status
Not yet recruiting
Address
Progressive Medical Research
Port Orange, Florida, 32127
Status
Not yet recruiting
Address
Clinical Research of West Florida
Tampa, Florida, 33606
Status
Recruiting
Address
Conquest Research
Winter Park, Florida, 32789
Status
Recruiting
Address
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Status
Recruiting
Address
Alliance for Multispecialty Research - Newton
Newton, Kansas, 67114
Status
Not yet recruiting
Address
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas, 67205
Status
Not yet recruiting
Address
Alliance for Multispecialty Research - Wichita East
Wichita, Kansas, 67207
Status
Not yet recruiting
Address
Tandem Clinical Research
Marrero, Louisiana, 77072
Status
Not yet recruiting
Address
Alliance for Multispecialty Research - Las Vegas
Las Vegas, Nevada, 89119
Status
Not yet recruiting
Address
Kaplan Medical Research
Las Vegas, Nevada, 89119
Status
Not yet recruiting
Address
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Status
Not yet recruiting
Address
Alliance for Multispecialty Research - Knoxville
Knoxville, Tennessee, 37909
Status
Not yet recruiting
Address
FutureSearch Trials - Austin
Austin, Texas, 78731
Status
Not yet recruiting
Address
Clinical Investigations of Texas
Plano, Texas, 75075
Status
Not yet recruiting
Address
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Status
Recruiting
Address
Diagnostics Research Group - Northwest San Antonio
San Antonio, Texas, 78229
Status
Not yet recruiting
Address
Discovery Clinical Trials
San Antonio, Texas, 78258
Status
Recruiting
Address
Emeritus Research
Botany, New South Wales, 2019
Status
Recruiting
Address
Australian Clinical Research Network
Maroubra, New South Wales, 2035
Status
Recruiting
Address
Griffith University
Southport, Queensland, 4222
Status
Recruiting
Address
Austrials Taringa
Taringa, Queensland, 4068
Status
Recruiting
Address
Austrials Wellers Hill
Tarragindi, Queensland, 4121
Status
Recruiting
Address
Sportsmed
Stepney, South Australia, 5069
Status
Recruiting
Address
Emeritus Research
Camberwell, Victoria, 3124
Status
Recruiting
Address
Linear Clinical Research Limited
Nedlands, Western Australia, 6009