A phase III, multicentric, single blind, randomized, comparative study to assess the efficacy and safety of Flupirtine Maleate Vs Tramadol Hydrochloride in patients with acute & subacute pain.
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
- 7
- 主要终点
- Efficacy will be assessed by improvement in following parameters:?Pain assessment (VAS )1?Pain Relief Rate2Based on a categorical transformation of the relative degree of pain relief rate :<25% = unrelieved25-49% = mere relief 50-74% = moderate relief 75-99%= significant relief100%= complete relief
研究概览
简要总结
It will be an open label, randomized trial involving minimum 200 PATIENTS WITH ACUTE AND SUBACUTE PAIN patients TO ASSESS THE SAFETY AND EFFICACY OF FUPIRTINE MALEATE VS TRAMADOL HYDROCHOLRIDE.DURATION OF TREATMENT WILL BE FIVE TO SEVEN DAYS PRIMARY OUTCOME OF THE TRIAL TO ASSESS AND COMPARE THEPain (Visual Analog Scale )Pain Relief Rate ,SECONDARY OUTCOME IS TO ASSESS THE ADVERSE EVENT AND CONSUMPTION OF RESCUE MEDICATION FOR 7 DAYS
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-65 years2 Both genders2 Patient willing to follow up and willing to comply with procedures and requirements Patient with signs & symptoms of acute, subacute pain, pain due to musculoskeletal condition, low back pain3, post operative pain, acute orthopedic conditions like bone fracture2 Patients who have received other medication for pain but having no improvement.
排除标准
- •Patients < 18 years and >65 years2Patients with hepatic encephalopathy.Patients suffering from myasthenia gravis.Patients with various liver disease Pregnant & lactating women2Orthopedic conditions showing degenerative changesKnown hypersensitivity to the Flupirtine Maleate or Tramadol HydrochloridePatients with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction2Participation in any other clinical trial in past 3 months.
结局指标
主要结局
Efficacy will be assessed by improvement in following parameters:?Pain assessment (VAS )1?Pain Relief Rate2Based on a categorical transformation of the relative degree of pain relief rate :<25% = unrelieved25-49% = mere relief 50-74% = moderate relief 75-99%= significant relief100%= complete relief
时间窗: 5-7 DAYS
次要结局
- Safety will be assessed based on analysis in the following variables:(?Adverse events)