Osteoarthritis – Stride HOPE4OA
Participating in a clinical trial with Profound means making a real difference in the lives of others facing similar health challenges.
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.
Inclusion Criteria:
- Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
- Clinical diagnosis of OA in the index knee by American College of Rheumatology 1986 criteria.
- 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.
- Average daily pain (ADP) numerical rating scale (NRS) score of 4-9 in the index knee at Screening.
- Baseline average weekly ADP NRS score of 4-9 in the index knee in the 7 days prior to randomization.
- No more than one 24-hr average pain score (0-10 NRS) reported as “10” during the 7 days prior to Day 1.
- Body mass index of ≥18.0 to ≤39.0 kg/m2.
- Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except allowed rescue medication) from 2 weeks before Day 1 to end of study.
- Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.
- Other criteria may apply
Complete the form and our team will reach out soon to help determine your eligibility.