Do you suffer from diabetes and diabetes-related pain in the lower limbs?

Have you ever wondered how new pharmaceutical products are researched?

We invite you to be part of this development process.

You will receive payment for your participation to reimburse you for your time and inconvenience.

Who is suitable for this study?

To qualify for participation in this study you must:

  • Be aged between 18 and 75 years (inclusive) at screening
  • Have a documented diagnosis of diabetes mellitus type 1 or type 2 (with a confirmed medical history available from your GP)
  • Have presence of diabetes-related pain in the lower limbs of the body
  • Have a body mass index (BMI) between =18.5 and =45.0 kg/m2 (inclusive). Your BMI is calculated using the formula: weight (in kilograms) divided by height (in metres) squared).

What’s in it for you?

Apart from helping medical research, we will also compensate you for your time and inconvenience in the form of a monetary payment.

You will receive up to £460 for your time on completion of the study.

What will happen?

This study is being conducted at our research facility at Croydon University Hospital in London. If you are interested in taking part you will need to contact us to register your interest.

If you successfully pass the telephone screening you will be invited to our facility where you will undergo a screening examination. This is vital to ensure you are eligible to take part in the trial.

You will be required to attend two screening visits 30 days before the start of the study. If you pass the screening visit you will be invited to take part in the study. 

Study Participation

Participation for this study requires you to attend up to 2 out-patient visits and one residential stay of 1 night and 2 days at our clinical unit at Croydon University Hospital. Your participation in this study will last approximately 35 days.

This includes the two screening visits (Visit 1 and Visit 2) within 30 days before the start of the study, one residential stay of 1 night/2 days at our unit (Visit 3) and a final follow up telephone call 3 days after the last dose of the study drug. 

Who we are

Richmond Pharmacology conducts medical research to help develop new medicines.

Our 2 research units are based in London at St George’s University Hospital and Croydon University Hospital. Richmond Pharmacology works with Hospital Consultants, Research Physicians, and Clinicians.

This study is sponsored by Abbott and has been approved by an independent research ethics committee.

What is this all about?

Richmond Pharmacology is conducting a clinical trial for a new experimental drug called ABT-639. ABT-639 is a calcium channel blocker being developed for the treatment of diabetic peripheral neuropathy, which is damage to nerves of the peripheral nervous system (the part of the nervous system that connects the brain and spinal cord to the limbs and organs).

The trial is being conducted at Richmond Pharmacology only.

If you take part in the study, you will receive either:

  • Oral ABT-639 and placebo (dummy drug) infusion;
  • Lidocaine* infusion (which is also used to treat neuropathic pain. In this study it will be used as a comparator to see how well the ABT-639 is working) and oral placebo (dummy drug);
  • Placebo (dummy drug) infusion and oral placebo (dummy drug).

* Lidocaine is a local anaesthetic injected through the skin which you may be familiar with from dental treatments or other conditions requiring numbness of pain. Intravenous Lidocaine is also used to treat pain such as the neuropathic pain that you have. The doses you will receive are similar to dose regimens used in pain clinics.

What are the possible side effects?

ABT-639 has previously been given to both healthy volunteers and patients. To date, the most common side effects are headaches, frequent urination, dizziness, diarrhoea, feeling tired, stomach ache, passing gas, feeling faint, pinkeye, stomach growling, redness and swelling of the inside of the nose, sleepiness, feeling restless, and redness, pain and swelling at the site of blood sampling or ECG (electrical heart recording) tabs.

Lidocaine is a widely used drug and so we understand the side effects much better. Side effects of Lidocaine at higher levels than expected to be used in this study include lightheadedness, oral numbness or tingling, dizziness, hearing disturbances, dysarthria (speech disorders), increased blood pressure, nausea and headache. At very high doses, more serious side-effects including seizures (convulsions) and cardiac arrest can occur but we will not be giving such high levels so only minor side-effects may occur, if any. It is unlikely  that any serious side-effects will occur; however,an anaesthetist who is familiar with the administration of Lidocaine and treatment of its side effects will be present throughout the Lidocaine infusion period and at least one hour after infusion completed.

As for all drugs during development, it is not possible to predict all side effects. All drugs may cause unforeseen complications that have not been previously reported.

Want to find out more?

If you are interested in finding out more please complete the enquiry form on the right and a member of our Volunteer Recruitment Team will be in contact with further details.

A detailed information sheet is available on request.

Other restrictions and exclusions apply – please ask for details.

The contents of this web page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.

No deductions will be made for Tax and insurance, it will be your own responsibility to report the payment to the relevant authorities. If you are in receipt of any benefits, the payment you receive for taking part in this study may affect your eligibility to those benefits. On occasion, we are required by law to disclose such payments when requested.

You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.

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