Efficacy and Safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in the Treatment of Patients with Acute Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Comparison of the proportion of patients reporting pain improvement (reduction in pain intensity with a VAS ≤20 mm) at 1, 3, 5, and 7 days of follow-up, according to their baseline measurement in each treatment group
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 safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in Patients With Acute Low Back Pain
详细描述
Researchers will compare the fixed-dose combination of Etoricoxib/Cyanocobalamin versus Etoricoxib in acute low back pain by comparing the proportion of patients that reported an improvement in pain during the 7 days of follow up. The adverse events related to the interventions will be registered during follow up.
Participants will:
- Be randomized into one of the 2 intervention groups (A or B)
- Visit the clinic in 3 occasions (day 0, day 3 of follow up and day 7 of follow up)
- In case needed the patient could take 50 mg of tramadol, as a rescue medication, previous authorization of de principal investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient with pain reported as moderate to severe intensity with ≥ 40 mm on the Visual Analog Scale (VAS).
- •At least 4 points on the "Douleur Neuropathique-4 items" (DN-4) scale.
- •Diagnosis of acute low back pain as a first-time episode or a previous episode 6 months before the enrollment day and lasting no more than 6 weeks.
- •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 in whom the 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 (Etoricoxib of Cyanocobalamin)
- •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.)
- •Active opioid and/or NSAID treatment including COX-2 inhibitors, reported in the medical record within the last 72 hours of study entry.
- •Patients with a history of congestive heart failure: NYHA II-IV.
- •Concomitant use of strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, etc.).
- •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
- •Low back pain due to a history of major trauma in the past 12 months (e.g., vertebral fracture, post-traumatic spondylolisthesis) or due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis).
- •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
Etoricoxib+Cyanocobalamin
Administered orally, 1 tablet a day for 7 days.
干预措施: Etoricoxib + Cyanocobalamin fixed dose (Drug)
Etoricoxib
Administered orally, 1 pill a day for 7 days.
干预措施: Etoricoxib fixed dose (Drug)
结局指标
主要结局
Comparison of the proportion of patients reporting pain improvement (reduction in pain intensity with a VAS ≤20 mm) at 1, 3, 5, and 7 days of follow-up, according to their baseline measurement in each treatment group
时间窗: 7 dyas
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. The patient will visit the clinic at days 0,3 and 7. The researcher will call the patient for follow up at days 1 and 5.
Number of participants with treatment-related adverse events through the patient's diary record.
时间窗: 7 dyas
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
- Assess and compare the degree of physical disability due to acute low back pain, measured through the Oswestry disability questionnaire at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.(7 days)
- Assess changes in the score on the "Douleur Neuropathique-4 items" scale (DN-4) at days 3 and 7 in each treatment group and in comparison with the baseline measurement.(7 days)
- Analyze the percentage change in pain intensity based on VAS score at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.(7 days)
- Comparison of the proportion of subjects with pain improvement (reduction in pain intensity) through VAS, ≥ 50% at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.(7 days)
- Analyze the average change in pain intensity according to VAS score at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.(7 days)
- Comparison of the proportion of subjects with pain improvement (reduction in pain intensity) through VAS, ≥ 30% at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.(7 days)
- Assess and compare the degree of disability to perform daily activities due to low back pain, reported through Roland-Morris questionnaire at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.(7 days)
- Report the number of patients who present therapeutic failure during the study among the treatment groups(7 days)