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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date26 Sep 1996 |
An Observational Follow-up Study to Investigate the Duration of Treatment Effect With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain
The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks.
Participants who completed pDay 162 of Study PARA_OA_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.
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
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 osteoarthritis pain.
Study details include:
The study duration will be up to 31 weeks per participant
The treatment duration will be 6 weeks.
The visit frequency will be twice weekly during treatment.
The visit frequency will be every 4 weeks during the follow-up period.
100 Clinical Results associated with Paradigm Biopharmaceuticals (USA), Inc.
0 Patents (Medical) associated with Paradigm Biopharmaceuticals (USA), Inc.
100 Deals associated with Paradigm Biopharmaceuticals (USA), Inc.
100 Translational Medicine associated with Paradigm Biopharmaceuticals (USA), Inc.