Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

602

Participants

Timeline

Start Date

October 19, 2021

Primary Completion Date

October 15, 2024

Study Completion Date

January 6, 2025

Conditions
Osteoarthritis, Knee
Interventions
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)

Trial Locations (33)

2035

Australian Clinical Research Network, Maroubra

4222

Griffith University, Southport

5069

Sportsmed, Stepney

6009

Linear Clinical Research Limited, Nedlands

29405

Coastal Carolina Research Center, North Charleston

32127

Progressive Medical Research, Port Orange

32720

University Clinical Research-Deland, DeLand

32789

Conquest Research, Winter Park

33125

LMG Research, Miami

33173

Well Pharma Medical Research, Corp., Miami

33606

Clinical Research of West Florida, Tampa

33765

Clinical Research of West Florida- Clearwater, Clearwater

37909

Alliance for Multispecialty Research - Knoxville, Knoxville

60611

Northwestern University Feinberg School of Medicine, Chicago

67114

Alliance for Multispecialty Research - Newton, Newton

67205

Alliance for Multispecialty Research - Wichita West, Wichita

67207

Alliance for Multispecialty Research - Wichita East, Wichita

75075

Clinical Investigations of Texas, Plano

77072

Tandem Clinical Research, Marrero

78229

Clinical Trials of Texas, Inc., San Antonio

Diagnostics Research Group - Northwest San Antonio, San Antonio

78258

Discovery Clinical Trials, San Antonio

78731

FutureSearch Trials - Austin, Austin

85281

Alliance for Multispecialty Research - Tempe, Tempe

85283

Fiel Family and Sports Medicine, Tempe

85712

Tucson Orthopaedic Institute, Tucson

89119

Alliance for Multispecialty Research - Las Vegas, Las Vegas

Kaplan Medical Research, Las Vegas

90703

Core Healthcare Group, Cerritos

91606

Providence Clinical Research, North Hollywood

91730

Prospective Research Innovations Inc., Rancho Cucamonga

91942

Biosolutions Clinical Research Center, La Mesa

91978

Encompass Clinical Research, Spring Valley

All Listed Sponsors
lead

Paradigm Biopharmaceuticals USA (INC)

INDUSTRY