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.

Bayer AG0 个研究点目标入组 80 人2021年11月16日

适应症europathic pain associated with diabetic peripheral neuropathy MedDRA version: 21.1Level: LLTClassification code 10067547Term: Diabetic peripheral neuropathic painSystem Organ Class: 100000004852 Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: europathic pain associated with diabetic peripheral neuropathy
发起方: Bayer AG
入组人数: 80
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2021年11月16日

结束日期

2022年11月21日

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Bayer AG

入排标准

入选标准

•1\. Adults \= 18 years of age at the time of signing the informed consent.
•2\. Have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM)
•3\. Have painful distal symmetrical sensorimotor diabetic neuropathy for at least 6 months prior to the screening and confirmed at screening via the modified Toronto Clinical Neuropathy Score with a score of at least 3\.
•4\. Weekly mean 24\-hour average pain Numeric Rating Scale (NRS) \= 4 with adequate variability (not the same score on all daily pain ratings) and compliance (non\-missing pain score on at least 6 out of 7 consecutive days) in daily pain recording during the 7\-day NRS baseline period.
•5\. Neuropathic pain according to the Douleur Neuropathique 4 Questions (DN4 questionnaire) at screening visit with a score of at least 4 out of 10\.
•6\.Participant should be on stable antidiabetic treatment for at least 3 months prior to the screening visit and there should be no pre\-planned changes to antidiabetic treatment during this study.
•7\. Participant is willing to use only rescue medication provided by the site and is willing to withdraw temporarily all other neuropathic pain medications which were in use before study participation.
•8\. Participant is willing and able to use the electronic hand\-held device on their own.
•9\. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•Are the trial subjects under 18? no

排除标准

•1\.Clinically significant cardiovascular or cerebrovascular disease including Acute coronary syndrome (ACS)/myocardial infarction /stroke/Transient ischemic attack (TIA) within previous 3 months before screening visit.
•2\. Major depressive episode within 6 months prior to screening. Patients with stable depression and on stable antidepressant dose (no change in medication and /or dosing regimen) for the past 6 months are allowed to participate, provided the antidepressant used is not listed under prohibited medications.
•3\. Any differential diagnosis of peripheral diabetic neuropathy (PDN) including but not limited to other neuropathies (e.g. vitamin B12 deficiency, Chronic Inflammatory Demyelinating Polyneuropathy), polyradiculopathies, central disorders (e.g. demyelinating disease), or rheumatological disease (e.g. foot arthritis, plantar fasciitis).
•4\. Concurrent malignancy or history of cancer (exception of basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening.
•5\. Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g. chronic bowel disease, Crohn’s disease, and ulcerative colitis).
•6\. Any serious or unstable diseases or conditions including psychiatric disorders that might interfere with the conduct of the study or the interpretation of the results.
•7\. Major surgery or radiological procedures (e.g. Percutaneous transluminal angioplasty (PTA) and stenting of peripheral vascular lesions in lower extremities) within 3 months before screening visit or scheduled during the study period, which might interfere pain response evaluation.
•8\. Symptomatic peripheral arterial disease in lower or upper extremities, including diabetic ulcers.
•9\. Use of live, attenuated, replication\-competent vaccines.
•10\. Previous use of strong opioids (e.g. oxymorphone, oxycodone) for neuropathic pain anytime, or topical use of capsaicin within 3 months prior to the screening visit.