A Randomized, Double-blind, Cross-over, Placebo-controlled, Multi-center, Phase 2a Study to Assess the Safety and Signal in Efficacy of BAY 2395840 in Patients With Diabetic Neuropathic Pain

  • STATUS
    Not Recruiting
  • participants needed
    75
  • sponsor
    Bayer
Updated on 3 December 2022
electrocardiogram
type 2 diabetes mellitus
sugars
antidiabetic agents

Summary

Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP), a condition in which diabetes results in pain due to nerve damage.

People with diabetes have high blood sugar levels. Over the time, high blood sugar levels can cause damage to the nerves in the body, which results in DNP. The nerve damage in this condition is localized in a stocking and glove like pattern and starts in the feet and can move upwards on your legs. Some patients also progress having pain in their fingers/hands. People with DNP have pain in these areas as well as reduction/loss of feeling, and at times light touch can feel like pain.

In this study, the researchers want to learn more about a new study treatment called BAY 2395840. BAY 2395840 works by blocking a receptor called the bradykinin B1 receptor, or B1R. This receptor is has been shown to play a role in pain perception.

The researchers also want to learn how well BAY 2395840 helps to reduce pain in the study participants. To answer this question, the researchers will measure how the participants' pain changes after taking BAY 2395840 compared to a placebo. A placebo looks like a treatment but does not have any medicine in it. The researchers also want to learn how safe BAY 2395840 is for the participants to take.

The study will include adults.

This will be a "crossover" study. In a crossover study, all the participants will receive both treatments (BAY 2395840 and placebo), but in a different order. All participants in this study will take BAY 2395840 and a placebo as tablets by mouth.

There will be 2 periods in the study. Participants taking BAY 2395840 during period 1 will switch to placebo during period 2 and vice versa. There will some time for the switch from one period to another to make sure that whatever tablet you received in period 1 is gone from your system before period 2 starts to allow for the best possible evaluation of each tablet without any confusing effects.

The study is double blinded meaning that neither you nor your doctor will know which drug you are on. The sequence of double-blind placebo and BAY treatment will be determined randomly by a computerized system.

During the study, the participants will visit their study site 13 times. Each participant will be in the study for about 16 weeks. The treatment duration will be about 11 weeks.

During the study, the study team will:

  • take blood and urine samples
  • do physical examinations
  • check the participants' overall health
  • check the participants' heart health using an electrocardiogram (ECG)
  • ask the participants about any medications they have been taking, and what adverse events they are having

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Details
Condition Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Peripheral Neuropathic Pain, Diabetes Mellitus
Treatment BAY2395840, Placebo for BAY2395840
Clinical Study IdentifierNCT05219812
SponsorBayer
Last Modified on3 December 2022

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