2024-513940-27-00已完成2 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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- • Change From Baseline in Average Daily Low Back Pain (LBP) Intensity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1
研究概览
简要总结
To evaluate the efficacy of DFL24412 80 mg-34 mg per os (p.o.) and DFL24412 40 mg-17 mg p.o. in chronic low back pain compared to KLS (80 mg) at week 1.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- End of study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent before the initiation of any study-specific procedures
- •Must be 18-65 years of age at the time of signing the Informed Consent Form (ICF)
- •Have a normal physical examination (except features of CLBP as per IC 4, 5, and 6), 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
- •Diagnosis of chronic low back pain (CLBP, pain localised below the costal margin and above the inferior gluteal folds with no known specific pathology, persisting/recurring for at least 3 months) with no substantial recent change in pain severity or clinical management, with or without lumbosacral radicular pain and/or radiculopathy
- •Clinically documented nociceptive and neuropathic components ((‘probable neuropathic pain’ as per International Association for the Study of Pain, IASP)
- •Report at least moderate pain (NRS ≥ 4) before randomization
- •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
- •If a female with childbearing potential, have a negative serum β-human chorionic gonadotropin (β-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 their female 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. Highly effective methods of birth control are listed in Appendix 4 of Protocol KLG
- •Have a negative COVID-19 antigen rapid test or have received vaccination for COVID-19
排除标准
- •History of major thoraco-abdominal or low back surgery in the last 3 months
- •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
- •History of bronchial asthma, peptic ulcer, gastrointestinal bleeding, ulceration or perforation
- •Crohn’s disease or ulcerative colitis
- •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)
- •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
- •Female patients who meet the following criteria: Pregnant, breast-feeding, and/or planning to become pregnant and/or breast-feed during the study
- •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 Visit 1
- •Be an employee or a relative of an employee of the investigational study center
- •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
- •Unable or unlikely to comply with the study protocol, to fulfill eDiary/ paper Diary and questionnaires appropriately or unsuitable for any other reason, as judged by the PI
- •CLBP due to malignancy, fibromyalgia, ochronosis, recent trauma, infection, juvenile scoliosis or congenital malformation
- •Previous diagnosis of psychosis, bipolar disorder, schizoaffective disorder, major depressive disorder or neurological disorder
- •CLBP management requiring opioids or surgery and interventional procedures planned in the following 3 months
- •Any concomitant use of antidepressants, anticonvulsants, opioids, nonsteroidal anti-inflammatory drugs, muscle relaxants, and/or any other prohibited medication as listed in Appendix 6 of Protocol KLG0121 during the trial or being anticipated by the investigator to be required
- •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
- •History of drug and/or alcohol abuse or dependence, excluding nicotine and caffeine
- •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)
- •Have serum creatinine level higher than 1.6 mg/dL or creatinine clearance < 60, or had renal transplantation or receiving renal dialysis
结局指标
主要结局
• Change From Baseline in Average Daily Low Back Pain (LBP) Intensity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1
• Change From Baseline in Average Daily Low Back Pain (LBP) Intensity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1
次要结局
- Change From Baseline in Average Daily Low Back Pain (LBP) Intensity as Measured by an 11-point Numeric Rating Scale (NRS) at the follow-up visit [Time Frame:, Day 21]
- Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) score at week 1
- Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at week 1
- Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at the follow-up visit [ Time Frame: Day 21]
- Number of Participants Withdrawn Due to Lack of Efficacy Week 1
- Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 1
- Patient Global Impression of Change (PGI-C) Score Week 1
- Change From Baseline in European Quality of Life Questionnaire-5 Dimension-5 Level (EQ-5D-5L) to Week 1
- Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument at Week 1
- Number of rescue interventions up to Week 1
- Physical examination (see 7.1.2) [time frame: end of treatment visit (Week 1) or withdrawal].
- Vital signs: blood pressure, heart rate and Body Temperature and ECG [time frame: end of treatment visit (Week 1) or early withdrawal].
- Safety Laboratory Tests: hematocrit, hemoglobin, red blood cells, platelets, white blood cells, differential white blood cells count, sodium, potassium, calcium, serum creatinine, urea, serum albumin, total bilirubin, fractionated bilirubin, ALT, AST, ALP, lypases and amylases [time frame: end of treatment visit (Week 1) or early withdrawal].
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [time frame: throughout the study].
研究者
Enrico Minnella
Scientific
Dompe' Farmaceutici S.p.A.
研究点 (12)
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