PARA_OA_002_PPS compared with Placebo in Knee Osteoarthritis Pain
Research type
Research Study
Full 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
IRAS ID
1004150
Contact name
Mukesh Ahuja
Contact email
Sponsor organisation
Paradigm Biopharmaceuticals (USA) Inc.
Eudract number
2021-004030-11
Clinicaltrials.gov Identifier
Research summary
This study is designed to investigate the dose and treatment effect of the study drug, pentosan polysulfate sodium (PPS), given as an injection for the treatment of knee Osteoarthritis (OA) pain in adult participants. As a capsule taken by mouth, PPS is globally approved and used in United States, Europe, UK and Australia for treatment of a chronic condition called interstitial cystitis which causes bladder pressure or pain and sometimes pelvic pain. The PPS used in this study has been developed into an injectable form which is injected under the skin of the abdomen or thigh.\nEach patient in this study will be randomised to receive either Pentosan Polysulfate Sodium or Placebo (liquid that contains no medicine). The study will consist of 2 parts (stage 1 and stage 2). In stage 1, the study will test 3 different doses of PPS compared with placebo for 6 weeks. Stage 1 will help determine the most effective and safe dose for stage 2. Stage 2 will study the chosen dose of PPS compared with placebo for 6 weeks. This is a double-blind study meaning that neither the participants nor the researchers will be told which treatment a participant receives.\nThe maximum study duration for each participant enrolled is approximately 28 weeks. Each participant will have a screening period to check study eligibility (up to 4 weeks), a treatment period to receive the PPS or placebo injections (for 6 weeks) and a follow-up period (of 18 weeks) to see whether the treatment has worked and is safe. During the study visits, patients will be required to undergo procedures including blood tests, patient questionnaires and imaging exams. After study completion, patients will be invited to enrol in an extension study. \nAbout 938 patients will be enrolled in this study (about half of them in stage 1 and about half of them in stage 2) in Australia, Europe, UK and US.
This study achieved its goals of identifying optimal dose for the said objective. It was realised that the dosages tested did not achieve expected outcomes. A next-phase study is planned, and the outcomes will be published in due course.REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0009
Date of REC Opinion
7 Feb 2022
REC opinion
Further Information Favourable Opinion