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

Conditions

• Osteoarthritis, Knee

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pentosan Polysulfate Sodium twice weekly — DRUG
  Subcutaneous injection, 2 mg/kg twice weekly for 6 weeks
• Placebo — DRUG
  Placebo, subcutaneous injection, twice weekly for 6 weeks

Study Details

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. * Approximately 466 participants will be enrolled into this study.

Key Dates

Start date

May 29, 2025

Status verified

Nov 2025

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

466 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: PPS
  Pentosan polysulfate sodium 2mg/kg twice weekly for 6 weeks
• Placebo Comparator: Placebo
  Placebo (Sodium Chloride Injection, 0.9%) twice weekly for 6 weeks

Primary Outcome Measure

Change from baseline at Day 112 in knee pain as assessed by the weekly average of daily pain (ADP) score on the numerical rating scale (NRS) 11-point (0-10) scale. [ Time Frame: Baseline, Daily to Day 112 ]

Central Contacts

• Donna Skerrett
  +1 (312) 771 9615
  [email protected]

Locations (40)

Find similar trials in Peoria, AZ

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