What’s happening?

An exciting study is now underway at St Pancras Clinical Research looking at a new treatment to relieve prolonged pain in or around a healed scar following thoracic or abdominal (torso region) surgery. Our staff at St Pancras Clinical Research have collectively had extensive experience in researching and treating chronic pain conditions.

Ipsen, a major French pharmaceutical company, has launched this study with St Pancras Clinical Research in London to test a potential new treatment for patients experiencing long-term pain in or around a scar, long after the scar itself has healed.

What does the trial involve?

This study is made up of two parts:

  1. Before subjects are enrolled on the study, it is important to identify if there might be the potential to benefit from the new treatment. This is done by assessing the pain relief after injections of a local anaesthetic (lidocaine), and comparing this to placebo (sham) injections. Pain perception (rated on a scale of 0-10) is assessed up to 24-hours after each injection. Subjects who ‘respond’ at this point – in other words, they experience significant pain relief from the local anaesthetic – will progress to the second part of the study.  
  2. In the second part of the study, three-quarters of the ‘responder’ participants will have the new treatment administered and the remaining quarter will receive the placebo treatment. The placebo contains no active substances but will look and be administrated in exactly in the same way as the active treatment. This is a ‘double-blind trial’, meaning that neither subjects nor the study doctor will know who receives the placebo and who the active treatment. Around Day 1 (the first dosage day) we will perform some baseline assessments, which include tests such as vital sign measurements, and subjects will be trained in how to use a provided wearable Actiwatch, which records the pain rating over the next 16 weeks. The assessments will be done by medical professionals to ensure the safety and well-being of the subjects throughout. 

Who can take part?  

All visits would take place at St Pancras Clinical Research’s clinic in central London by King’s Cross station. Reasonable travel costs will be reimbursed and subjects who complete the trial will receive £700 to compensate for their time. The trial itself would last for around 22 weeks for each participant.

To take part, subjects must have had surgery on the torso region leaving a thoracic (chest) or abdominal (stomach) scar, and be between the ages of 18-75. There needs to be persistent (every day) pain in or around the scar and the surgery should have taken place within the last 10 years.

Find out more on Clinical Trials.gov:

https://clinicaltrials.gov/ct2/show/NCT03663101

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