FDC products in PDN
Research type
Research Study
Full title
Efficacy and safety of Fixed-Dose Combination (FDC) products containing trazodone and gabapentin in patients affected by painful diabetic neuropathy: randomized, controlled, dose finding study.
IRAS ID
242210
Contact name
Paola Lipone
Contact email
Sponsor organisation
Angelini S.p.A.
Eudract number
2018-000133-12
Clinicaltrials.gov Identifier
DIAB 37418, NIHR CRN reference
Duration of Study in the UK
1 years, 7 months, 11 days
Research summary
Painful diabetic neuropathy (PDN) is a common complication of diabetes. This is a chronic and progressive condition and greatly affects many aspects of a patient’s daily functions, including mood, sleep, self-worth, independence, ability to work and interpersonal relationships.
The first step in the management for this condition is the glycemic control and the correction of any other metabolic derangements. In addition to controlling hyperglycemia, patients often require management of their pain symptoms.
The major classes of drugs used to treat PDN are antidepressant and antiepileptic. For example, gabapentin is a well-known anticonvulsant, currently approved for epilepsy and neuropathic pain treatment. Data from a clinical trial concluded that gabapentin was effective in managing neuropathic pain and it has been found that gabapentin can offer the most favourable balance between safety and efficacy.Unfortunately, neuropathic pain is very difficult to treat and at the moment no drug is available yet to provide complete pain relief.
In this trial, Angelini S.p.A. is developing a fixed-dose combination medicinal product for the treatment of neuropathic pain containing two active ingredients: trazodone, a well-known antidepressant drug, and gabapentin which has a full product license for treatment of all types of peripheral neuropathic pain in the European Union.
The present phase II study is designed to collect preliminary data on the efficacy and safety of trazodone/gabapentin Fixed-Dose Combination (FDC) products for the treatment of patients affected by PDN in a randomized controlled clinical trial.
About 240 patients with painful diabetic neuropathy are planned to be enrolled in the study in 4 European countries; aged 17-85 years, with pain persisting or taking pain medication for neuropathic pain for at least 3 months.
The maximum duration of patient participation in the study will be about 9 weeks from the first drug intake, and for a total of 10 visits.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0236
Date of REC Opinion
18 Oct 2018
REC opinion
Further Information Favourable Opinion