Efficacy and Safety of the Fixed-Dose Combination of Etoricoxib / Tizanidine Versus Etoricoxib in the Treatment of Patients With Acute Low Back Pain Associated to Muscle Spasm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Comparison of the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 of follow-up relative to baseline, within each treatment group.
研究概览
简要总结
This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial. The aim of the study is to evaluate the efficacy and safety of a fixed-dose combination of etoricoxib and tizanidine compared to etoricoxib alone in patients with acute low back pain associated with muscle spasms.
详细描述
Researchers will compare the efficacy of a fixed-dose combination of etoricoxib and tizanidine versus etoricoxib alone in the treatment of acute low back pain associated with muscle spasms. Efficacy will be assessed by evaluating the average change in pain among patients who report improvement over the 7-day follow-up period. Adverse events related to the interventions will be recorded throughout the study.
Participants will:
- Be randomized into one of two intervention groups (Group A or Group B).
- Attend three in-person clinic visits: Day 0 (baseline), Day 3, and Day 7 of follow-up.
- Receive follow-up phone calls on Days 1 and 5.
- Be allowed to take 500 mg of acetaminophen as rescue medication if needed, with prior authorization from the 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
- •Willing to participate in the study and provide written informed consent.
- •Diagnosis of acute low back pain, either as a first-time episode or following a previous episode within the past 6 months, with a duration not exceeding 6 weeks.
- •Pain associated with lumbar muscle spasm, assessed through physical examination (muscle hypertonia and/or reflex scoliosis) and clinical history.
- •Patient reports moderate to severe pain intensity (VAS ≥ 40 mm).
- •Patients with a Neuropathic Pain Questionnaire (DN4) score <
- •For women of childbearing age who are sexually active, the use of an acceptable contraceptive method (barrier and/or hormonal) as determined by the investigator.
- •At the discretion of the Principal Investigator (PI) or treating physician, the patient is eligible for treatment with the investigational product and may benefit from it.
排除标准
- •Patients with a history of hypersensitivity to any components of the investigational product (Etoricoxib/Tizanidine) or their derivatives (as reported in the medical history and clinical interview).
- •Patients participating in another clinical trial involving an investigational treatment or who have participated in one within the past 2 weeks before the study begins.
- •Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable populations, etc.).
- •Patients for whom the investigational drug is contraindicated for medical reasons.
- •Positive pregnancy test, pregnant women, breastfeeding women, or those planning a pregnancy during the study period.
- •Significant history of gastrointestinal disorders (e.g., active gastric ulcer, Crohn's disease, ulcerative colitis, etc.).
- •Prior treatment with opioids and/or NSAIDs, including COX-2 inhibitors, as reported in the medical history within 48 hours before study enrollment.
- •Patients with a history of congestive heart failure: NYHA class II-IV.
- •Concomitant use of potent CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, etc.).
- •History of alcohol or drug abuse within the past year.
- •Patients with a history of established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease (including patients who have recently undergone coronary revascularization procedures or angioplasty).
- •Patients with a history of seizure disorders, status epilepticus, or grand mal seizures.
- •History of liver disease classified as Child-Pugh A, B, or C, as reported in the medical history or clinical interview.
- •History of acute or severe renal failure (glomerular filtration rate <30 ml/min/1.73 m²), as reported in the medical history or clinical interview.
- •Patients with a history of chronic musculoskeletal pain (e.g., fibromyalgia, Paget's disease, cancer-induced metastatic bone pain).
- •Patients diagnosed with low back pain due to a history of major trauma within the past 12 months (e.g., vertebral fracture, post-traumatic spondylolisthesis), a visceral disorder (e.g., dysmenorrhea, history of endometriosis), or a neuropathic component.
- •At the physician's discretion, any disease that affects prognosis and prevents outpatient management, which must be evaluated by the principal investigator to determine the subject's eligibility.
- •History or presence of any disease or condition that, in the investigator's opinion, could pose a risk to the patient or confound the efficacy and safety assessment of the investigational product.
- •Patients with symptoms suggesting an active COVID-19 infection (e.g., fever, cough, dyspnea) and/or contact with a suspected or confirmed COVID-19 case in the last 14 days.
- •Oncology patients (except for basal cell skin cancer) or those with severe illnesses who, in the investigator's opinion, have a severe prognosis or a life expectancy of less than one year
研究组 & 干预措施
Etoricoxib+Tizanidine
Administered orally, 1 sachet a day for 7 days.
干预措施: Etoricoxib + Tizanidine fixed dose (Drug)
Etoricoxib
Administered orally, 1 sachet a day for 7 days.
干预措施: Etoricoxib fixed dose (Drug)
结局指标
主要结局
Comparison of the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 of follow-up relative to baseline, within each treatment group.
时间窗: 7 days
The Visual Analog Scale (VAS) for pain is a straight line anchored by two descriptors: one end indicating no pain and the other representing the worst pain imaginable. The investigator will administer the VAS at each study visit to assess pain intensity. At the end of the clinical trial, the percentage change in pain scores from baseline will be calculated and compared between treatment groups.
Number of participants reporting treatment-related adverse events, as documented in the patient diary.
时间窗: 7 days
To describe the frequency, intensity, and causality of adverse events reported during the clinical trial, stratified by treatment group. Adverse events will be recorded by patients in their diary logs. Each event will be monitored and followed up at the discretion of the investigator.
次要结局
- Determine the follow-up time point at which each treatment group demonstrates the greatest reduction in pain intensity, as measured by the Visual Analog Scale (VAS).(7 days)
- Analyze the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7, compared to baseline, within and between each treatment group.(7 days)
- Compare the proportion of patients in each treatment group who achieve a ≥30% reduction in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 relative to baseline.(7 days)
- Compare the proportion of patients in each treatment group who achieve a ≥50% reduction in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 relative to baseline.(7 days)
- Compare the proportion of patients in each treatment group according to the severity of lumbar muscle spasm, as assessed by the Investigator's Global Subjective Assessment.(7 days)
- Assess and compare the degree of disability in performing daily activities due to low back pain, as reported using the Roland-Morris Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline.(7 days)
- Assess and compare the degree of physical disability caused by acute low back pain, as measured by the Oswestry Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline.(7 days)