An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination tablets containing Etodolac & Tolperisone hydrochloride in comparison with Tolperisone hydrochloride tablets in patients suffering from musculoskeletal disorders associated with painful muscle spasm.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.
研究概览
简要总结
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination tablets of Etodolac 400 mg & Tolperisone hydrochloride 150 mg and Tolperisone hydrochloride 150 mg tablets given thrice a day each for a maximum of 14 days or till complete muscle spasm relief is obtained, whichever is earlier; in 200 patients with musculoskeletal disorders associated with painful muscle spasm that will be conducted in five centers only in India. The primary outcome measures will be the degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline..
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex between the age of 18-60 years.
- •2.Patients with an established diagnosis of musculoskeletal disorders associated with painful muscle spasm of at least moderate severity at the time of enrolment into the study.
- •3.Informed consent of the patient/relative/legal representative.
排除标准
- •1.Pregnancy & Lactation.2.Patients with hepatic and / or renal insufficiency.3.Patients with myasthenia gravis.4.Patients with active peptic ulceration within the last 6 months.5.Patients suffering from coronary heart disease, uncontrolled hypertension, congestive heart failure or any other significant cardiovascular disorder.6.Patients suffering from any hemorrhagic diasthesis.
- •7.Patients with bronchial asthma, rhinitis, urticaria, or other allergic reactions induced by aspirin or other NSAIDs.8.Patients with hypersensitivity to Etodolac, Tolperisone hydrochloride or any other components of the formulations.9.Patients with any other serious concurrent illness or malignancy.10.Patients with continuing history of alcohol and / or drug abuse.11.Participation in another clinical trial in the past 3 months.
结局指标
主要结局
The degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.
时间窗: 0,3,7,10 & 14 days
次要结局
- (1)The degree of improvement in the individual scores of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.((2)The investigators? global assessment of efficacy at the end of the study.)