Chronic Low Back Pain

Persica Pharmaceuticals has designed a drug called PP353 to treat Chronic Low Back Pain.  This is the first research study 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 study, 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 study 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 study.  You will be followed up in the study 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 study, 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 study doctor who can pass this information on to you.

What is a clinical study? 

• A clinical study is a scientific study on how a new or existing medicine, product, procedure or treatment works in people.
• Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
• All clinical studies are carefully monitored and regulated to ensure participant well-being.
• Participating in a clinical study is completely voluntary
   

What happens if you decide to participate?

In summary, The Modic Trial will need a significant commitment from you: 

• Several checks will be done to make sure you are suitable for the trial and not everybody will be able to enter the clinical trial;
• 2 injections will be given over 5 days;
• You would be on the trial for up to 14 months requiring regular visits to the hospital, especially in the first 3 months;
• After the first 3 months the visits to the hospital are approximately every 3 months;
• You have to be available for phone calls at specified times during the study;
• You will need to complete the electronic diary regularly during the study;
• Tell your study team about any other medicines that you take, even if it is a medicine you buy without a prescription. You are asked not to take any other medication without speaking to your study doctor first;
• Report all experienced side effects and changes in your health;
• You cannot take long term antibiotic therapy for any reason for the duration of the study.
  • Should you need to take long term antibiotics you will need to stop taking part in this study;
  • Short courses of antibiotics are allowed after discussion with your study doctor;  
• If you are a woman, you must not be currently breastfeeding or plan to get pregnant while in the study and for 1 month after you finish the study.
• If you are a man, you must not cause your partner to become pregnant in the 100 days following the injection. You must agree not to donate sperm until 100 days after the injection.   

How can bacteria get into a spinal disc?

It may seem strange to think that bacteria can get into a spinal disc and that antibiotics might be able to reduce that pain. However, in patients with a slipped disc (known as disc herniation) the outer tough rings of the disc split open, and some of the soft gel in the centre of the disc-the nucleus–breaks through the outer rings. Bacteria are then able to enter the disc via the bloodstream. 

Can antibiotics help patients with Chronic Low Back Pain?

Several clinical studies have shown that long term treatment of 100 days with high dose oral antibiotics can reduce pain in patients with Chronic Low Back Pain. This long and high dose antibiotic treatment is thought to be necessary because discs do not normally have any blood vessels and it is difficult for the antibiotics to get into the infected area and kill the bacteria.  Unfortunately, patients treated with long term oral antibiotics also frequently experience unpleasant side effects. There are also concerns with long term antibiotic use and bacteria becoming resistant to the antibiotics.  This clinical trial will use an antibiotic that is injected directly into the spinal disc.

Recovery

This is a clinical research trial with a medication that has not been used this way in humans before.  Furthermore, you may not get benefit from the clinical trial medication.

You should be aware that patients may be initially disappointed when they receive antibiotic treatment because they expect to get well quickly. It can take up to 12 months before your Chronic Low Back Pain is better. First the bacteria must be killed; it then takes some months for the situation to heal and the muscles to regain their strength.  Reduction in pain may be only after this process.  When this happens, the patient may experience less back pain. This is why you will stay in the study for a year to assess your progress.

When your pain slowly improves you can start gentle exercise and slowly progress within your pain limits.