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Diabetic Neuropathic Pain clinical trials

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NCT ID: NCT06336486 Completed - Clinical trials for Diabetic Neuropathic Pain

the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated

NCT ID: NCT05563454 Completed - Healthy Volunteers Clinical Trials

A Study to Learn How Safe the Study Treatment BAY2395840 is, How it Affects the Body and How it Moves Into, Through, and Out of the Body if Given in Single and in Repetitive Doses to Japanese Healthy Male Participants

Start date: October 11, 2022
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP). DNP is pain due to damage to the nerves in the extremities that can occur in patients with diabetes as a result of blood sugar levels being too high for too long. BAY2395840 works by blocking specific receptors. A receptor is a protein inside or on the surface of a cell that binds to a specific substance and causes a specific effect in the cell. BAY2395840 specifically blocks so-called bradykinin B1 receptor, whose activation is involved in inflammatory responses. This blockage may help to relieve pain and inflammation. BAY2395840 has already been studied in clinical studies with European people. However, data for Japanese people are still missing. The participants of this study do not benefit from this study. However, the study will provide information on how to use BAY2395840 in later studies with Japanese people. The main purpose of this study is to learn how safe the study drug BAY2395840 is and how it affects the body if given in single and in repetitive doses to Japanese healthy male participants. To answer this question, the researchers will collect and analyze the medical problems the participants have after taking BAY2395840 and that may or may not be related to the study treatments. These medical problems are also known as "adverse events". In addition, the study team will learn how BAY2395840 moves into, through and out of the body if given in single and in repetitive doses to Japanese healthy male participants. For this, the researchers will collect data on: - the (average) highest level of BAY2395840 in the blood (also referred to as Cmax) - the (average) total level of BAY2395840 in the blood (also referred to as AUC) during the treatment period with the study drug on day 1 and for the repetitive dose group only (see below), on day 7. Subsequently, the study team will compare the data between those participants who received the study drug BAY2395840 (from different dosing groups) and those participants who received placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. All study participants will be randomly (by chance) assigned to 1 of 5 treatment groups. Dependent on the treatment group, the participants will either take: - a single dose of the lowest, middle and highest BAY2395840 dose (treatment groups 1 to 3) - repetitive doses of the highest BAY2395840 dose (treatment group 4) or - placebo (treatment group 5). The participants will take their treatments as dosage form 1 after diet 1. The treatment period with repetitive doses of BAY2395840 will be 7 subsequent days. The participants from treatment groups 1 to 3 will have an in house-period of 8 days including 7 overnight stays. The participants from treatment group 4 will have an in house-period of 12 days including 11 overnight stays. The study duration will be approximately 6 weeks per participant for dose groups 1 to 3 and approximately 7 weeks per participant for dose group 4. During the study, the study team will: - take blood and urine samples - do physical examinations - check the vital signs such as blood pressure, heart rate, body temperature - examine heart health using electrocardiogram (ECG). About 10 to 14 days after the participants take their last treatment, the study doctors and their team will check the participants' health.

NCT ID: NCT04487431 Completed - Overactive Bladder Clinical Trials

A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)

Start date: August 5, 2020
Phase: Phase 1
Study type: Interventional

Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis) or a condition where the cough lasts longer than 8 weeks in adults (chronic cough). BAY1817080 is a new drug that is in development as a potential treatment for these conditions. In this trial, the researchers want to learn how a new liquid form of BAY1817080 is taken up by the body in a small number of healthy participants. The trial will include men who are aged 18 to 54. The trial will have 2 parts: A and B. The participants in Part A will stay at the trial site for about 5 days. During this time, the participants will take 1 dose of a liquid form of BAY1817080 by mouth. The doctors will take blood and urine samples and check the participants' health. Part A will be done so the researchers can see how much BAY1817080 gets into the participants' blood. The participants in Part B will stay at the trial site for about 16 days followed by a maximum of 4 re-admission visits over 24 hours at intervals of 7 days. These participants will take 1 dose of a liquid form of BAY1817080 labeled with a radioactive substance (carbon 14), which means it is "radiolabeled". This allows the researchers to understand how BAY1817080 moves through and leaves the body. During Part B, the doctors will take blood, urine, stool, and vomit samples if applicable. They will also check the participants' health.

NCT ID: NCT04471337 Completed - Overactive Bladder Clinical Trials

Study on the Safety of BAY1817080 How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given to Participants With Moderate Renal Impairment and End Stage Renal Disease Requiring Dialysis Compared With Matched Participants With Normal Renal Function

Start date: August 12, 2020
Phase: Phase 1
Study type: Interventional

BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). Especially in elderly patients with OAB or RUCC, renal impairment is frequent. Renal impairment which co-occurs in especially in elderly patients with OAB or RUCC is a common condition in which the kidneys are not filtering the blood as well as they should. End stage renal disease (ESRD) requiring hemodialysis is a condition in which patients kidneys are no longer able to work as they should and require treatment to filter wastes from the blood. The goal of the study is to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and excretes the study drug given in men and women with moderate renal impairment and with those who have end stage renal disease (ESRD) requiring dialysis compared with matched participants with normal kidney function.

NCT ID: NCT04454424 Completed - Overactive Bladder Clinical Trials

Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function

Start date: July 23, 2020
Phase: Phase 1
Study type: Interventional

BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). In this study researchers want to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as tablet in participants with mild, moderate or severe hepatic impairment and participants with normal liver function matched for age-, gender-, weight and race. The study will enroll 36 male and female participants in the age between 18 and 79 years. Participants with mild or moderate hepatic impairment and the matching participants will take multiple oral doses of study drug depending on the study plan. Participants with severe hepatic impairment and the matching participants will take a single oral dose of study drug during the study. Data from this study will provide researcher important information for further development of the study drug in particular on dose recommendation for patients with hepatic impairment.

NCT ID: NCT04265781 Completed - Overactive Bladder Clinical Trials

Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants

Start date: February 15, 2020
Phase: Phase 1
Study type: Interventional

Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins expressed on the sensory nerves of the womb tissue, bladder or airway which are oversensitive in the patients with endometriosis (a condition where the tissue that usually grows inside the womb grows outside of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or more frequently) and long-standing cough with or without clear causes. Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be either one single dose of study drug/placebo received on only one day or multiple doses of study drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day. The total study duration for each participant will be usually no more than 42 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT02783469 Completed - Clinical trials for Diabetic Neuropathic Pain

Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee)

GoDARTS
Start date: October 2004
Phase:
Study type: Observational

In 1997, the global prevalence of diabetes was estimated to be 125 million and this has risen to around 400 million in 2015. In addition diabetes has a number of complications including heart disease, blindness, kidney failure and amputation. This represents a significant burden on healthcare services. Type 2 diabetes (T2D) is caused by a combination of genetic and environmental factors. The aim of GoDARTS is to recruit participants with T2D to a registry to provide a platform with which to investigate the genetics of T2D, its complications and response to treatment. This study will investigate the genetic basis of diabetic neuropathic pain.

NCT ID: NCT01589432 Completed - Clinical trials for Diabetic Neuropathic Pain

A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral Neuropathy

Start date: April 2012
Phase: Phase 2
Study type: Interventional

People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

NCT ID: NCT01345045 Completed - Clinical trials for Diabetic Neuropathic Pain

A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

Start date: April 2011
Phase: Phase 2
Study type: Interventional

People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

NCT ID: NCT00548925 Completed - Clinical trials for Diabetic Neuropathic Pain

A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Start date: November 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy