Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain
Public ClinicalTrials.gov record NCT04809376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared With Placebo in Participants With Knee Osteoarthritis Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04809376
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 602 participants
Conditions and interventions
Conditions
Interventions
- Pentosan Polysulfate Sodium twice weekly Drug
- Placebo (Sodium Chloride Injection, 0.9%) Drug
- Pentosan Polysulfate Sodium Fixed Dose Drug
- Pentosan Polysulfate Sodium once weekly Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 19, 2021 (Actual)
- Primary completion
- Oct 15, 2024 (Estimated)
- Completion
- Jan 6, 2025 (Estimated)
- Last update posted
- Apr 8, 2024
2021 – 2025
United States locations
- U.S. sites
- 29
- U.S. states
- 10
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Multispecialty Research - Tempe | Tempe | Arizona | 85281 | — |
| Fiel Family and Sports Medicine | Tempe | Arizona | 85283 | — |
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | — |
| Core Healthcare Group | Cerritos | California | 90703 | — |
| Biosolutions Clinical Research Center | La Mesa | California | 91942 | — |
| Providence Clinical Research | North Hollywood | California | 91606 | — |
| Prospective Research Innovations Inc. | Rancho Cucamonga | California | 91730 | — |
| Encompass Clinical Research | Spring Valley | California | 91978 | — |
| Clinical Research of West Florida- Clearwater | Clearwater | Florida | 33765 | — |
| University Clinical Research-Deland | DeLand | Florida | 32720 | — |
| LMG Research | Miami | Florida | 33125 | — |
| Well Pharma Medical Research, Corp. | Miami | Florida | 33173 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Clinical Research of West Florida | Tampa | Florida | 33606 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Alliance for Multispecialty Research - Newton | Newton | Kansas | 67114 | — |
| Alliance for Multispecialty Research - Wichita West | Wichita | Kansas | 67205 | — |
| Alliance for Multispecialty Research - Wichita East | Wichita | Kansas | 67207 | — |
| Tandem Clinical Research | Marrero | Louisiana | 77072 | — |
| Alliance for Multispecialty Research - Las Vegas | Las Vegas | Nevada | 89119 | — |
| Kaplan Medical Research | Las Vegas | Nevada | 89119 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| Alliance for Multispecialty Research - Knoxville | Knoxville | Tennessee | 37909 | — |
| FutureSearch Trials - Austin | Austin | Texas | 78731 | — |
| Clinical Investigations of Texas | Plano | Texas | 75075 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Diagnostics Research Group - Northwest San Antonio | San Antonio | Texas | 78229 | — |
| Discovery Clinical Trials | San Antonio | Texas | 78258 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04809376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2024 · Synced Nov 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04809376 live on ClinicalTrials.gov.