Who is sponsoring NCT04809376?

NCT04809376 is sponsored by Paradigm Biopharmaceuticals USA (INC).

What drugs are being tested in NCT04809376?

Interventions in NCT04809376: Pentosan Polysulfate Sodium twice weekly, Placebo (Sodium Chloride Injection, 0.9%), Pentosan Polysulfate Sodium Fixed Dose, Pentosan Polysulfate Sodium once weekly.

What condition does NCT04809376 study?

NCT04809376 studies Osteoarthritis, Knee.

Is NCT04809376 still recruiting?

NCT04809376 is currently active, enrolled. Last updated 8 April 2024.

Last reviewed 2024-04-08 · How we verify

NCT04809376

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2, PHASE3 Last updated 8 April 2024

What this trial tests

Phase 2, PHASE3 trial testing Pentosan Polysulfate Sodium twice weekly in Osteoarthritis, Knee in 602 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 October 2021

Primary endpoint
15 October 2024

6 January 2025

Quick facts

Lead sponsor	Paradigm Biopharmaceuticals USA (INC)
Phase	Phase 2, PHASE3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	602
Start date	19 October 2021
Primary completion	15 October 2024
Estimated completion	6 January 2025
Sites	33 locations across United States, Australia

Drugs / interventions tested

Pentosan Polysulfate Sodium twice weekly — full drug profile →
Placebo (Sodium Chloride Injection, 0.9%) — full drug profile →
Pentosan Polysulfate Sodium Fixed Dose — full drug profile →
Pentosan Polysulfate Sodium once weekly — full drug profile →

Conditions studied

Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Paradigm Biopharmaceuticals USA (INC) — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting Aggrecanases for Osteoarthritis Therapy: From Zinc Chelation to Exosite Inhibition.
Cuffaro D, Ciccone L, Rossello A, Nuti E, et al · · 2022 · cited 31× · PMID 36250680 · DOI 10.1021/acs.jmedchem.2c01177
The current state of the osteoarthritis drug development pipeline: a comprehensive narrative review of the present challenges and future opportunities.
Kim H, Seo J, Lee Y, Park K, et al · · 2022 · cited 28× · PMID 36504595 · DOI 10.1177/1759720x221085952

Verify or expand the search:

Other recruiting trials for Osteoarthritis, Knee

Currently open trials in the same condition.

NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT06488144 — Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans · Phase 3 · recruiting
NCT07386561 — Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty · NA · active not recruiting
NCT07514598 — Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA) · NA · active not recruiting
NCT07058623 — Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04809376 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Paradigm Biopharmaceuticals USA (INC)
Last refreshed: 8 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04809376.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing