A Comparative, Randomized Parallel group, Multicentric Prospective Phase III Clinical trial to evaluate Efficacy and Safety of a Fixed Dose Combination of Thiocolchicoside 16mg SR + Aceclofenac 200mg SR Capsule OD compared with FDC of Thiocolchicoside 8mg + Aceclofenac 100mg Tablet BID for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain associated with muscular spasm.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Comparison percent of reduction in pain within the last 24 hours assessed using VAS at Day 4 in both treatment groups.
研究概览
简要总结
The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs) and laboratory investigations LFT and RFT and evaluation of pain on VAS. Female subjects of child bearing capability will be subjected to a urine pregnancy test. Enrolled subjects will receive the medication for 4 days (Visit 2). At visit 3 efficacy and ADR evaluation will be done and medication for another 3 days dispensed. At visit 4 end of therapy efficacy, safety, tolerability and ADR monitoring will be done. The reduction in intensity of pain would be assessed by VAS and the safety evaluation would be done by analyzing the lab parameters (LFT and RFT). Subjects are allowed to visit to investigator at any time point during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 75.00 Year(s)（—）
入选标准
- •Age Eligible for study: 20 years to 75 years Gender Eligible for study: both Accepts Healthy Volunteers: No Non specific low Back pain with an acute episode of recent onset (<48 hours) defined by average pain within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS) Low Back pain of diagnosis category 1 (low Back pain radiating no farther than the intergluteal fold) or 2 (low Back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain.
- •Willing to give written informed consent.
排除标准
- •Backache due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders.
- •Backache of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain.
- •History of inflammatory arthritis of large joints.
- •History of seizure disorders.
- •History of malignant tumor.
- •Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids.
- •Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission.
- •Psychiatric or mental diseases.
- •Immune Compromised HIV.
- •Inclusion in another study in the past six months or previous inclusion in this study.
- •History of alcohol, drugs or narcotics abuse.
- •Recent history of violent trauma.
- •Constant progressive, non mechanical pain (no relief with bed rest).
- •Thoracic pain.
- •Patient systemically unwell.
- •Unexplained weight loss.
- •Structural deformity.
- •Clinical significant renal dysfunction defined by Creatinine more than 1.5 mg/dl.
- •Clinically significant hepatic dysfunction defined by: Total Bilirubin more than 2 mg/dl.
- •SGOT (AST) more than 1.5 IU/L.
- •SGPT (ALT) more than 1.5 IU/L.
- •Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy.) within the last 48 hours.
- •Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.
结局指标
主要结局
Comparison percent of reduction in pain within the last 24 hours assessed using VAS at Day 4 in both treatment groups.
时间窗: Baseline and completion of treatment
次要结局
- Average reduction pain within the last 24 hours assessed using VAS by Investigator and Subject at day 7 i.e. completion of protocol treatment in both treatment groups.(Baseline and completion of treatment)