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Also known as Pentosan Polysulfate Sodium twice weekly
Pentosan Polysulfate twice weekly · 1 trial · 1 indication
WOMAC: The WOMAC® NRS 3.1 Index is a validated, self-administered, health status questionnaire that assesses pain, stiffness, and function in patients with hip or knee OA . The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours. It is calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain sub-scale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
| Arm | Type | Description |
|---|---|---|
| PPS Twice Weekly | EXPERIMENTAL | Pentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks |
| PPS Once Weekly | EXPERIMENTAL | Pentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks |
| PPS Fixed Dose Once Weekly | EXPERIMENTAL | Pentosan Polysulfate Sodium (PPS) Fixed dose (100mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo twice weekly for 6 weeks |
| Name | Type | Description |
|---|---|---|
| Pentosan Polysulfate Sodium twice weekly | DRUG | Subcutaneous Injection, 1.5mg/kg Ideal body Weight (IBW) |
| Placebo (Sodium Chloride Injection, 0.9%) | DRUG | Placebo to match PPS |
| Pentosan Polysulfate Sodium Fixed Dose | DRUG | Subcutaneous Injection, 100/150/180 mg if \<65kg/ ≥ 65 kg and ≤ 90kg/ \>90 kg IBW |
| Pentosan Polysulfate Sodium once weekly | DRUG | Subcutaneous Injection, 2.0mg/kg Ideal body Weight (IBW) |
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 criteria 1986 criteria. * Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-...
Pentosan Polysulfate twice weekly is an investigational small molecule being studied for the treatment of knee osteoarthritis. It is administered by subcutaneous injection twice weekly and is currently in Phase 2 clinical development for this musculoskeletal condition.
Pentosan Polysulfate twice weekly is being developed by BrainsWay Ltd. (NASDAQ: BWAY). The company is conducting a Phase 2 clinical trial to evaluate the treatment for knee osteoarthritis.
Pentosan Polysulfate twice weekly is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being evaluated in an active clinical trial for knee osteoarthritis.
Pentosan Polysulfate twice weekly is being studied in clinical trial NCT04809376, titled 'Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain.' This Phase 2, randomized, double-blind, placebo-controlled trial has an enrollment of 602 participants and is active but not recruiting.
Yes, Pentosan Polysulfate twice weekly is also known as Pentosan Polysulfate Sodium twice weekly. Both names refer to the same investigational drug being developed for knee osteoarthritis.