A randomized, placebo-controlled, double-blind, parallel-group, multicenter combined Phase 2a/2b study to assess the efficacy and safety of BAY 1817080 in patients with diabetic neuropathic pain - PUCCINI

Bayer AG0 个研究点目标入组 440 人开始时间: 2020年10月19日最近更新: 2022年1月10日

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: 440

研究概览入排标准研究者记录与标识符相似试验

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. At the time of screening, have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM) with painful distal symmetrical sensorimotor neuropathy of more than 6 months duration according to modified Toronto Clinical Neuropathy Score.
•3. Weekly mean 24-hour average pain 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.
•4. Neuropathic pain according to the DN4 questionnaire.
•5. Women of childbearing potential must agree to use acceptable effective or highly effective birth control methods.
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

排除标准

•1. 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).
•2. 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. excessively low body weight, chronic bowel disease, Crohn's disease and ulcerative colitis).
•3. 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.
•4. Major surgery or radiological procedures (e.g. 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.
•5. Symptomatic peripheral arterial disease in lower or upper extremities, including diabetic ulcers.
•6. 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.
•7. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for study participants.
•8. Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C.
•9. 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.
•10. Glycemic control unstable (hemoglobin HbA1c =11%) within 3 months prior to screening (e.g. ketoacidosis requiring hospitalization, any recent episode of hypoglycemia requiring assistance through medical intervention, uncontrolled hyperglycemia).
•11. 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.
•12. 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).
•13. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 calculated by Modification of Diet in Renal Disease (MDRD) formula (local formulas will be used where applicable.
•14. 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

发起方

Bayer AG

相似试验

进行中（未招募）

1 期

A study to test whether study drug BAY1128688 brings pain relief to women with endometriosis and if so to get a first idea which dose(s) work best.MedDRA version: 20.0Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disordersEndometriosis

EUCTR2017-000244-18-PLBayer AG121

进行中（未招募）

1 期

A study to test whether study drug BAY1128688 brings pain relief to women with endometriosis and if so to get a first idea which dose(s) work best.MedDRA version: 20.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000024185MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disordersEndometriosis

EUCTR2017-000244-18-NLBayer AG121

进行中（未招募）

1 期

EUCTR2017-000244-18-ATBayer AG120

已完成

不适用

A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intakeHealthy subjects

JPRN-UMIN000033854HUMA R&D CORP62

进行中（未招募）

1 期

A Phase 2a, randomized, placebo-controlled, double-blind study to investigate REM0046127 in mild to moderate Alzheimer's diseaseMedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 100000004852Alzheimer's Disease

EUCTR2022-000080-43-ESreMYND60