EUCTR2021-001629-38-ES进行中（未招募）1 期
A phase 2, multicenter, randomized, double blind, active controlled, parallel group study assessing the analgesic effect and safety of two doses of DFL24412 in patients with chronic low back pain compared to Ketoprofen Lysine Salt (KLS).
Dompè Farmaceutici S.p.A.0 个研究点目标入组 150 人开始时间: 2021年9月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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. Provide written informed consent before the initiation of any study-specific procedures
- •2. Must be 18-65 years of age at the time of signing the Informed Consent Form (ICF)
- •3. Have a normal physical examination, vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
- •4. Diagnosis of persistent nonspecific chronic low back pain (CLBP, pain localised below the costal margin and above the inferior gluteal folds with no known specific pathology, persisting for at least 3 months), with no substantial recent change in pain severity or clinical management
- •5. Documented nociceptive and neuropathic components (DN4 >/= 4 for neuropatic component)
- •6. Report at least moderate pain (NRS>/= 4) before randomization
- •7. If undergoing physical and/or exercise-based therapy for back pain, therapy must be stable at least three weeks prior to study and remain the same throughout study
- •8. If a female with childbearing potential, have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test; Women of childbearing age and potential must be willing to use highly effective contraception during the study and for 3 months after the last study treatment dose. Male patients and theirfemale partners of childbearing age and potential must be willing to use effective contraception during the study and for 3 months after the last study treatment dose.
- •9. Have a negative COVID-19 antigen rapid test or have received vaccination for COVID-19
- •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 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. History of major thoraco-abdominal or low back surgery in the last 3 months
- •2. CLBP due to malignancy, fibromyalgia,ochronosis, recent trauma, infection, juvenile scoliosis or congenital malformation
- •3. Previous diagnosis of psychosis, bipolar disorder, schizoaffective disorder, major depressive disorder or neurological disorder
- •4. CLPB management requiring opiod or surgery
- •5. Any concomitant use of antidepressants and/or anticonvulsants, opioids, nonsteroidal anti-inflammatory drugs, muscle relaxants, and/or any other prohibited medication during the trial or being anticipated by the investigator to be required
- •6. Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
- •7. History of drug and/or alcohol abuse or dependence, excluding nicotine and caffeine
- •8. Have alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL)
- •9. Have serum creatinine level higher than 1.6mg/dL or creatinine clearance <60, or had renal transplantation or receiving renal dialysis
- •10. Severe or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic diseases, symptomatic peripheral vascular disease, hemorrhagic diathesis, haemolytic anemia, systemic immune-mediated and rheumatologic disorders, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
- •11. History of bronchial asthma, peptic ulcer, gastrointestinal bleeding, ulceration or perforation
- •12. Crohn’s disease or ulcerative colitis
- •13. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (antiHCV) or human immunodeficiency virus I and II antibodies (anti-HIV I/II)
- •14. History of intolerance or hypersensitivity to: ketoprofen lysine salt or other drugs of the same class, gabapentin, rescue medications, component of the formulation; any history of severe drug allergy or hypersensitivity
- •15. Female patients who meet the following criteria: Pregnant, breast-feeding, and/or planning to become pregnant and/or breast-feed during the study
- •16. Treatment with any investigational product (IP) during the study and within the 3 months (or at least 5 half-lives, whichever is longer) prior to Visit1
- •17. Be an employee or a relative of an employee of the investigational study center
- •18. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
- •19. Unable or unlikely to comply with the study protocol, to fulfill eDiary and questionnaires appropriately or unsuitable for any other reason, as judged by the PI
研究者
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