clinical


clinical

CLINICAL TRIALS


BMELs and Osteoarthritis

A phase 2b, randomised double blind placebo controlled multicentre study to evaluate the effects of pentosan polysulfate sodium on treating pain in subjects with osteoarthritis of the knee and subchondral bone marrow lesions

There is increasing evidence that bone marrow edema lesions (BMLs) play an important role in the development of knee OA. In established OA, BMLs are associated with knee pain and progression (on x-ray or MRI) of knee OA and cartilage loss. The potential for PPS to improve outcomes for patients with OA and BMLs is supported by real world evidence.

Paradigm is now conducting a phase 2b clinical trial (randomised, placebo-controlled) to investigate PPS in subjects with BMLs and OA. The trial is now fully recruited. For full details, please see the entry on the ANZCTR website here.

Ross River Virus (RRV)

A pilot study to investigate the effects of pentosan polysulfate sodium in Ross River virus induced arthralgia

With reports of an increasing number of people infected in the recent outbreak of RRV in Victoria*, Paradigm is pursuing research to provide hope to those patients who suffer persistent and debilitating arthritis and joint pain following RRV infection.  Having received ethics approval in May 2017, recruitment for Phase II clinical trials in the treatment of RRV (Australia) commenced in July 2017. Recruitment for the trial has now closed, and details can be viewed here, on the Australian New Zealand Clinical Trials Registry.

* Human and Health Services (2017). Surveillance of Notifiable Conditions. Victoria: Victorian State Government.

Bone marrow edema (BME)

A pilot study investigating the short-term outcome of intramuscular administration of pentosan polysulfate sodium for the treatment of bone marrow lesions of the knee

In 2016, we commenced an open label clinical trial to investigate the safety, tolerability and efficacy of ZILOSUL® in the treatment of patients with a ruptured Anterior Cruciate Ligament (ACL) injury. Paradigm announced the successful completion of the trial in November 2017. More details of this announcement can be found here.

Allergic Rhinitis (AR)

A phase 2, randomised, double-blind, placebo-controlled, crossover study to evaluate the effects of a topical pentosan polysulphate sodium (PPS) formulation in subjects with seasonal allergic rhinitis

In December 2016, Paradigm commenced a Phase II clinical trial in Lund, Sweden, evaluating one of the nasal spray PPS formulations under development. In January 2017 we announced successful recruitment of 40 subjects into the trial.  Progress and results from the trial have been shared via our ASX announcements on the 16th and 19th of June, 2017.

For additional details on the Phase I trial, completed in 2016, click here.

clinical trials Pipeline