A Control- Labeled, Prospective, Randomized, Parallel group, Multicentric, Phase III Clinical Trial to Evaluate Efficacy and Safety of Eperisone HCl SR Capsule compared with Eperisone HCl Tablet in patients suffering from Acute Musculoskeletal Spasm associated with Low Back Pain.

Inventia Health Care Pvt Ltd6 个研究点分布在 1 个国家目标入组 200 人开始时间: 2010年7月24日最近更新: 2013年3月21日

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: 6
主要终点: Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 4 in both treatment groups.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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). Female volunteers 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 inintensity 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: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Patients of either sex between 18 to 70 years of age.
•Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to: Spondylosis deformans.
•Prolapsed Intervertebral Disc (PID).
•Muscle sprains with spasms.
•Patients who are willing to take the medications as directed and willing to come for follow-ups.
•Patients who are willing to comply with the protocol requirements.
•Patients who are willing to give the written informed consent.

排除标准

•Patients with other associated spasm conditions like traumatic pain with spasms, cervical spondylitis and pain and spasm associated with fractured bone.
•Patients who had taken any form of skeletal muscle relaxant in the previous seven days Patients with hypersensitivity to any of the ingredients of the study drug formulations.
•Women of child bearing potential not following adequate contraceptive measures Patients unwilling or unable to comply with the study procedures Patients having a history of severe acute infection, major surgery, trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding eight weeks Patients having severe hepatic insufficiency defined by an SGOT or SGPT value equal or higher than the three fold normal values of the respective laboratory reference value Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism, Nephrotic syndrome, Anorexia nervosa, biliary obstruction and severe cardiac dysfunction.
•Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder Patients that have received treatment with any investigational drug in the preceding four weeks.

结局指标

主要结局

Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 4 in both treatment groups.

时间窗: day 4

次要结局

Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at Day7 i.e. completion of protocol treatment in both treatment groups.(Day 7)

研究者

发起方

Inventia Health Care Pvt Ltd

申办方类型

Pharmaceutical industry-Indian

研究点 (6)

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