Efficacy and Safety Study of Celecoxib / Pregabalin / Vitamin B Fixed Dose Combination Versus Celecoxib + Vitamin B Versus Pregabalin + Vitamin B in the Management of Chronic Low Back Pain Mixed Component
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Comparison of the percentage change of Celecoxib / Pregabalin / Vitamin B Combination versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B in the management of chronic low back pain through the visual analog pain scale (VAS).
研究概览
简要总结
Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and security of the drug combination of Celecoxib / Pregabalin / Vitamin B versus Celecoxib + Vitamin B, versus Pregabalin + Vitamin B in the treatment of chronic low back pain.
详细描述
Researchers will compare the fixed-dose combination of Celecoxib/Pregabalin/Vitamin B versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B for chronic low back pain. The adverse events related to the interventions would be registered in each follow up visit.
Participants will:
- Be randomized into one of the 3 intervention groups (A,B,C) once a day for 12 weeks
- If needed the dose could be escaleted twice a day.
- Visit the clinic at weeks 2, 4, 8 and 12 for checkups and follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to participate in the study and give written informed consent
- •Subjects must have chronic low back pain with a high probability of a significant neuropathic component during 4 years or less (but not less than 3 months)
- •Patients with chronic low back pain reported as moderate to severe intensity (EVA ≥ 40 mm)
- •Patients with Neuropathic Pain Questionnaire (DN4) result ≥ 4
- •Women of childbearing potential under a medically acceptable method of contraception
排除标准
- •Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
- •Patients whose participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
- •At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures
- •History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the efficacy and safety of the investigational product
- •Patients in whom the study drug is contraindicated for medical reasons
- •Patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients
- •Pregnant women, women breastfeeding or planning a pregnancy during the conducting the study
- •Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.)
- •Current treatment with opioids and/or NSAIDs including COX-2 inhibitors (except celecoxib), reported in clinical history in the last 24 hours to the signing of the informed consent
- •Patients who are receiving monoamineoxidase inhibitors (MAOIs) or who have received them in the course of the 2 weeks prior to signing the informed consent
- •Patients with a history of alcohol or drug abuse in the last year
- •Patients with a history of ischemic heart disease, peripheral artery disease, and/or cerebral vascular disease (including patients who have recently undergone coronary revascularization or angioplasty)
- •Patients with a history of seizures, epileptic status and/or grand mal seizures
- •History of chronic liver failure Child-Pugh A, B, and/or C
- •History of acute renal failure (glomerular filtration rate <30 ml/min/1.72 m2)
- •Patient with a history of chronic pain associated with fibromyalgia, Paget's disease or bone pain induced by metastatic cancer
- •History of major trauma to the lower back in the past 14 days
- •Low back pain due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis)
- •Patients with a history of orthopedic surgery of the lumbar region secondary to chronic low back pain
- •Patients with symptoms suggestive of COVID-19 infection (fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19
研究组 & 干预措施
Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo
Administered orally, 1 tablet + 1 capsule a day, for 3 months.
干预措施: Celecoxib+Pregabalin+Vitamin B fixed dose (Drug)
Celecoxib + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)
Administered orally, 1 capsule + 1 tablet a day, for 3 months
干预措施: Celecoxib + Vitamin B fixed dose (Drug)
Pregabalin + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)
Administered orally, 1 capsule + 1 tablet a day, for 3 months
干预措施: Pregabalin + Vitamin B fixed dose (Drug)
结局指标
主要结局
Comparison of the percentage change of Celecoxib / Pregabalin / Vitamin B Combination versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B in the management of chronic low back pain through the visual analog pain scale (VAS).
时间窗: 3 months
The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the change porcentage will be measured and compared between treatment groups.
Number of participants with treatment-related adverse events through the patient's diary record.
时间窗: 3 months
To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.
次要结局
- To describe the sociodemographic characteristics of the patients included in the study by treatment group(3 months)
- Assess the proportion of patients who reported >30% improvement in pain intensity measured through VAS at 12 weeks per treatment group(3 months)
- Assess the proportion of patients who reported >50% improvement in pain intensity measured through VAS at 12 weeks per treatment group(3 months)
- Assess and compare the degree of disability to perform daily activities due to low back pain, reported through Roland-Morris questionnaire at 4 and 12 weeks per group treatment(3 months)
- Assess and compare health status through the 5-level, 5-dimensions EuroQol questionnaire (EQ-5D-5L) at 12 weeks from baseline in each group of treatment(3 months)
- Report the number of patients that required dose escalation(3 months)
- Report the number of patients who require the use of rescue medication during the clinical trial by treatment group.(3 months)
- Report the number of patients who presented therapeutic failure during the study among the treatment groups(3 months)
- To report the percentage of therapeutic adherence at 12 weeks of intervention by group of treatment.(3 months)
- Blood concentration of BUN of the patients included in the study by treatment group(3 months)
- Assess at what time of follow-up the greatest reduction in pain intensity was achieved, measured through VAS, per treatment group.(3 months)
- Assess and compare the degree of physical disability due to low back pain, measured through the Oswestry disability questionnaire at 4 and 12 weeks per treatment group.(3 months)
- Blood concentration of glucose of the patients included in the study by treatment group(3 months)
- Blood concentration of urea of the patients included in the study by treatment group(3 months)
- Blood concentration of creatinin of the patients included in the study by treatment group(3 months)
- Blood concentration of Alkaline Phosphatase of the patients included in the study by treatment group(3 months)
- Blood concentration of total bilirrubin of the patients included in the study by treatment group(3 months)