Which drug is being researched?
The drug is called PP353 and has been designed to treat Chronic Low Back Pain.
The Modic Trial is the first research trial using PP353 and it will check the safety of PP353, how PP353 moves through the body (pharmacokinetics) and find out if PP353 reduces back pain.
PP353 contains an antibiotic and has been specially designed to treat infections in spinal discs. In this trial, PP353 will be injected directly into a single spinal disc.
40 patients will be randomised (like ‘flipping a coin’) to receive one of two treatments, PP353 or placebo (dummy treatment). Neither you nor your trial doctor will know which treatment has been assigned to you.
All patients will receive 2 injections, approximately 5 days apart (e.g., Monday and Friday). Half of the patients will be randomised to receive 2 injections of PP353 into the disc. The other half will receive 2 placebo injections. During a placebo injection a needle will be inserted into your muscle, close to (but not into the disc) and nothing will be injected.
You will receive anesthetic – in most cases local anesthetic – before each injection.
You can continue to use your normal pain medication during the trial. You will be followed up in the trial for one year (12 months). PP353 will only stay in your body for a short time but it may take several months before your body responds and we know if it helps your back pain.
At the end of the trial, you have the right to be informed of the overall results of this research. The outcome of the trial will be shared by the Persica Pharmaceuticals with your trial doctor who can pass this information on to you.