Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate

Status Active, not recruiting

Clinical Trial Summary

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: - The study duration will be up to 31 weeks per participant - The treatment duration will be 6 weeks. - The visit frequency will be twice weekly during treatment. - The visit frequency will be every 4 weeks during the follow-up period.

Clinical Trial Description

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: - 1.5 mg/kg calculated for ideal body weight (IBW) PPS twice weekly - 2 mg/kg IBW PPS once weekly + placebo once weekly - 100/150/180 mg PPS if ≤ 65 kg/ ≥ 65 kg and ≤ 90kg/ > 90kg IBW+ placebo once weekly - placebo twice weekly In Stage 2, approximately 470 participants will be randomized 1:1 to receive the selected PPS dose regimen or placebo for 6 weeks. Approximately 150 participants (75 per group) will be assigned to the PK subset. Participants in Stage 2 will be randomly allocated to receive: - One of the 3 Stage 1 PPS dose regimens selected by the DMC - placebo twice weekly The maximum duration for each participant is approximately 31 weeks, which includes: - 7-week Screening Period from Day -45 to Day -1 - 6-week Treatment Period from Day 1 to Day 39 - 18-week Follow-up Period from Day 40 to Day 168 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04809376
Study type	Interventional
Source	Paradigm Biopharmaceuticals Ltd.
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	October 19, 2021
Completion date	January 6, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03895489` - Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses	N/A
Completed	`NCT03660943` - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain	Phase 3
Completed	`NCT04531969` - Comparison of Outpatient and Inpatient Spa Therapy	N/A
Completed	`NCT02848027` - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment	Phase 3
Completed	`NCT05160246` - The Instant Effect of Kinesiology Taping in Patients With Knee OA	N/A
Recruiting	`NCT06080763` - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed	`NCT03643588` - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain	N/A
Active, not recruiting	`NCT05100225` - Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis	Phase 2
Active, not recruiting	`NCT04061733` - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis	N/A
Completed	`NCT04051489` - A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Recruiting	`NCT05546541` - Epidemiology and Nutrition
Recruiting	`NCT05447767` - Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg	Phase 2
Not yet recruiting	`NCT04448106` - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis	Phase 2
Not yet recruiting	`NCT03225911` - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis	N/A
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Completed	`NCT05703087` - Positive Cueing in Knee Arthroplasty.	N/A
Not yet recruiting	`NCT06042426` - Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population	Phase 4
Completed	`NCT02881775` - Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis	N/A
Completed	`NCT02905747` - The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis	N/A
Terminated	`NCT02909257` - Motor-Sparing Femoral Nerve Block Dose	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms