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A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.

NCT06917404 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2026-05-08

No results posted yet for this study

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 OA pain.

Study details include:

* The study duration will be up to 64 weeks.
* The treatment duration will be 6 weeks.
* The visit frequency will be twice weekly during treatment.
* The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period.
* Approximately 466 participants will be enrolled into this study.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Pentosan Polysulfate Sodium twice weekly

Subcutaneous injection, 2 mg/kg twice weekly for 6 weeks

DRUG

Placebo

Placebo, subcutaneous injection, twice weekly for 6 weeks

Sponsors & Collaborators

  • Paradigm Biopharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer, Medical · Paradigm Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Hong Kong
  • Moldova

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917404 on ClinicalTrials.gov