Observational Follow-up Study of PPS in Knee Osteoarthritis Pain
Research type
Research Study
Full title
An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants with Knee Osteoarthritis Pain
IRAS ID
313805
Contact name
Hemant Pandit
Contact email
Sponsor organisation
Paradigm Biopharmaceuticals (USA) Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
145770, IND
Duration of Study in the UK
2 years, 10 months, 28 days
Research summary
This study aims to evaluate the duration of treatment effect and safety of pentosan polysulfate sodium (PPS) in patients with knee osteoarthritis (OA) pain who have previously been treated with PPS or placebo (dummy drug that contains no medicine) by injection in the parent study, PARA_OA_002.
This is an observational follow-up study where participants will not receive any study drug, and will only attend 3 follow-up visits by phone and an end of study hospital visit, for various assessments such as questionnaires, physical exam, MRI scan, and x-ray.
Participation in this study will last approximately 34 weeks.
Approximately 938 participants will be enrolled in the parent study PARA_OA_002 across Europe, US and Australia, and all participants who have completed the parent study will be invited to participate in this study, PARA_OA_006.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0158
Date of REC Opinion
23 May 2022
REC opinion
Favourable Opinion