EUCTR2021-001392-17-SK进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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.
- •11. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for study participants.
- •12. Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C.
- •13. Have platelets = 100 x 109/L, or neutrophil count < 1.2 x 109/L (or equivalent), hemoglobin = 100 g/L for women or hemoglobin = 110 g/L for men at screening.
- •14. Glycemic control unstable (hemoglobin HbA1c =11% or 97 mmol/mol) within 3 months prior to screening (e.g. ketoacidosis requiring hospitalization, any recent episode of hypoglycemia requiring assistance through medical intervention, uncontrolled hyperglycemia).
- •16. ALT >2xULN, or AST >2xULN, or total bilirubin greater than ULN, or alkaline phosphatase (AP) >2x ULN, or INR greater than ULN (unless related to anticoagulation treatment) at screening.
- •17. Positive hepatitis B virus surface antigen (HBsAg) or positive hepatitis C virus antibodies (anti-HCV) and detection of mRNA (HCV-mRNA tested only if hepatitis C virus antibodies detected).
- •18. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 calculated by Modification of Diet in Renal Disease (MDRD) formula.
- •19. Uncontrolled hypertension despite optimal treatment with antihypertensive(s), indicated by a sitting systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg.
研究者
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