NNUH research team presented with award for Meniere’s disease clinical trial
A team from the Norfolk and Norwich University Hospital (NNUH) has been presented with an award in recognition of its role in a clinical trial to find a treatment for Meniere’s disease.
The award was received from INC Research, a global contract research organisation which monitors the work of clinical research teams. Meniere’s disease is an uncommon disorder that affects the inner ear. It can cause vertigo, tinnitus, hearing loss and a feeling of pressure deep inside the ear.
The NNUH research has been led by clinical research nurse Catherine Wright who said: “We have been running a number of clinical trials on behalf of a US company called Otonomy, with their investigational drug OTO-104.”
OTO-104 is a suspension of dexamethasone in a solution, that gels at body temperature. OTO-104 is being developed for the treatment of vertigo associated with Meniere’s disease, which is considered the most debilitating symptom of the disease. OTO-104 is a slow-release treatment which stays in the ear for a prolonged period of time.
Catherine said: “The first study we were involved with was a phase two study. During this study we recruited patients with a diagnosis of Meniere’s disease. Patients were given OTO-104 injections into the ear, and we were interested in looking at the safety aspects of the injection.
“The phase two study was a tremendous success and we were the highest recruiter in the UK. We are now recruiting patients for the phase three study and this time we are recruiting patients who have active [Meniere’s] disease. For this phase, patients are required to complete symptom diaries to determine the effectiveness of these injections.”
In the trial, patients are given injections of either OTO-104 or placebo to determine the effectiveness of the drug.
The research team involved in the trial is made up of staff from the pharmacy department, the ENT and audiology department, four members of nursing staff and the research and development team. The principal investigator for the Norwich trial is Consultant ENT Surgeon, Mr John Phillips. Mr Phillips is also the national coordinating investigator for the whole of the UK.
Mr Phillips said: “For patients, clinical trials represents an opportunity to receive potentially cutting-edge treatments which would otherwise be unavailable.
“The Otonomy trial was originally carried out only in the US. I feel honoured to have been selected to lead this national trial which is active in 18 major centres throughout the UK.
“I specialise in treating patients with tinnitus, dizziness and vertigo. Unaffected members of the public really don’t appreciate how distressing these conditions can be. These conditions are complicated and can have significant effects on an individual’s mental well-being as well as their physical well-being. Being able to take part in clinical research not offers patients the opportunity to potentially benefit themselves, but patients feel that they are helping fellow sufferers who have been experiencing the same symptoms.
“Clinical research at NNUH is certainly putting Norwich on the map. NNUH is a great hospital, that provides great care for a diverse range of conditions. Attracting the attention of major research organisations is amazing and I am very proud.
“To receive an award from INC Research is a great achievement. It has been awarded in recognition of the excellent conduct displayed by the whole team. I am very lucky to be supported by an excellent nursing team led by Catherine, a conscientious pharmacy team, a well organised Research and Development department, and a supportive group of fellow consultant colleagues and audiologists.”
Meniere’s sufferer Colin Breeze, from King’s Lynn, took part in the OTO-104 treatment trial and said: “Congratulations to John Phillips, Catherine Wright and the team on receiving this award.
“I am and will remain greatly indebted to them for their skills and treatment I received as part of the clinical trial. It has brought life changing relief from Meniere’s disease which turned my world upside-down so this recognition is very well-deserved.”
Phase I trials assess the safety of a drug and usually include number of healthy volunteers.
Phase II trials assess the efficacy of a drug.
Phase III trials involve larger numbers of people and aim to demonstrate safety and effectiveness of a drug.