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

NCT04809376 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2024-04-08

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 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.

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)

Sponsors & Collaborators

  • Paradigm Biopharmaceuticals USA (INC)

    lead INDUSTRY

Principal Investigators

  • Thomas Schnitzer · Northwestern University Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2024-10-15
Completion
2025-01-06
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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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 NCT04809376 on ClinicalTrials.gov