19636 - BRADiNP
Research type
Research Study
Full title
A randomized, double-blind, cross-over, placebo-controlled, multi-center, Phase 2a study to assess the safety and efficacy of BAY 2395840 in patients with diabetic neuropathic pain.
IRAS ID
1004320
Contact name
Karita Saarinen
Contact email
Sponsor organisation
Bayer AG
Eudract number
2021-001392-17
Research summary
Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP). People with diabetes have high blood sugar levels and over time this can cause damage to the nerves in the body which can result in pain.
Nerve damage can start in the feet and move up the legs and sometimes progresses to pain in the fingers and hands. Patients can have reduction and/or a loss of feeling, where at times light touch can feel like pain.
The aim is to learn more about and how safe a new treatment called BAY2395840 is. This works by blocking the bradykinin B1 receptor (B1R) that has been shown to play a role in pain perception. The researchers will measure the participants’ pain changes after taking BAY2395840 compared to a placebo.
The study participants are adults. This is a crossover, double blind study where all participants take BAY2395840 and a placebo tablets in a different order, by mouth, where neither the participant nor doctor will know which drug they are on. Participants taking BAY2395840 during period 1 will switch to placebo during period 2 and vice versa. Time is allotted between periods to ensure the tablet taken in 1st period is out of the system before starting period 2 allowing best possible evaluation of each tablet without confusing effects.The participants will be on the study for approximately 16 weeks, visit the site 13 times with 11 weeks of study treatment. The following assessments will be made:
• blood/urine samples taken
• physical examinations
• overall health check
• participants’ heart health checked via electrocardiogram (ECG)
• participants will be asked about any medications they have been taking, and any medical problems that arise during study.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0277
Date of REC Opinion
31 Dec 2021
REC opinion
Further Information Favourable Opinion