V3381 in Diabetic Peripheral Neuropathic Pain (Version 1)
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Parallel Group Study of the Safety, Tolerability and Efficacy of V3381 for Up to 13 Weeks in Patients with Diabetic Peripheral Neuropathic Pain (DPNP)
IRAS ID
14612
Sponsor organisation
Vernalis (R&D) Ltd
Eudract number
2008-007978-38
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
The study is designed to test how safe and effective V3381 is in a particular type of pain, known as neuropathic pain, which can occur as a complication of diabetes. V3381 is an investigational medicine (that is, a medicine which is still being tested) which works by two different mechanisms, both of which have previously been shown to be useful in treating this type of pain. One hundred and fifty patients will be randomly assigned in equal numbers to receive either V3381 or identical placebo capsules. Patients will take V3381 or placebo for up to 15 weeks. They will start taking a low dose (100 mg twice a day) and increase this over a period of 4 weeks to a maximum dose of 400 mg twice a day. During the study patients will complete electronic diaries every day to record the severity of their pain, and will attend the clinic on 9 occasions at which time they will complete other tests. These other tests will record the impact that study treatment has on specific aspects of their pain, their general well-being and their quality of life. Patients participating in the trial will undergo routine safety tests including blood tests, blood pressure and heart rate monitoring, electrocardiograms to check their heart rhythm and recording of any side effects which might have occurred.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
09/H0605/6
Date of REC Opinion
12 Feb 2009
REC opinion
Further Information Favourable Opinion