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NCT06917404RECRUITINGIRB Ready

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

Sponsored by Paradigm Biopharmaceuticals Ltd.

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Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Participant must be โ‰ฅ18 years of age inclusive, at the time of signing the informed consent. 2. Clinical diagnosis of OA in the index knee by American College of Rheumatology 1986 criteria. 3. Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee. 4. Participant is unresponsive for at least 6 months preceding Screening to any two combinations of OA therapies (one from each A and B) within the last 12 months that include: A.) conservative non-pharmacologic therapy (exercise, weight loss, physical therapy) or simple analgesics (e.g., acetaminophen) and B.) pharmacological treatment (topical or oral NSAIDs \[or cyclooxygenase (COX) inhibitor\], or intra-articular \[IA\] injections), or participant is unable to take NSAIDs because of contraindication or inability to tolerate. 5. Average daily pain (ADP) numerical rating scale (NRS) score of 4-9 in the index knee at Screenin

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

466 participants

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Gender

ALL

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Sponsor

Paradigm Biopharmaceuticals Ltd.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Peoria

Arizona

Location available
View Peoria location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Anaheim

California

Location available
View Anaheim location page
RECRUITING

Cerritos

California

Location available
View Cerritos location page
RECRUITING

Daytona Beach

Florida

Location available
View Daytona Beach location page
RECRUITING

Hialeah

Florida

Location available
View Hialeah location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Orlando

Florida

Location available
View Orlando location page
RECRUITING

Port Orange

Florida

Location available
View Port Orange location page

๐Ÿ“ And 18 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Knee Osteoarthritis Treatment in Winter Park?

Join others in Florida exploring innovative treatment options through clinical research

Knee Osteoarthritis Treatment Options in Winter Park, Florida

If you're searching for Knee Osteoarthritis treatment in Winter Park, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Winter Park, Lincoln, Box Hill and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Knee Osteoarthritis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 466 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Knee Osteoarthritis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Knee Osteoarthritis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Knee Osteoarthritis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06917404. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.