CTRI/2010/091/006069已完成3 期
A prospective, controlled, randomized, open, comparative, parallel, 2-arm study to evaluate the efficacy and safety of FDC tablet containing Tolperisone (150mg) and Diclofenac (50mg) in patients suffering from acute muscle spasms
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Pain intensity (recorded on VAS), tenderness (graded from 0 to 3), joint mobility (recorded on VAS), Spasm relief (recorded on VAS), need for rescue medication. Time needed for the patient to be symptom free.
研究概览
简要总结
This study is a controlled, randomized, open, comparative, parallel, 2-arm study to evaluate the efficacy and safety of FDC tablet containing Tolperisone 150 mg and Diclofenac 50 mg in patients suffering from acute muscle spasms.
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 in the age group between 18 to 70 years.
- •Patients painful muscle spasms and contractions associated with cervical and lumbar spondylosis, rheumatoid arthritis, osteoarthritis, blunt superficial trauma, low back pain.
- •Subjects who provide a written informed consent to abide by the study requirements.
排除标准
- •Patients with acute muscle spasms who need parenteral therapy / surgery / hospital admission for management.
- •Patients treated with any other oral / parenteral muscle relaxants, analgesics (NSAIDS & Opioids) medications within 1 week prior to the study.
- •Patients suffering from organic neurological disorders (Upper motor neuron disorders, cerebral palsy, pyramid tract injury, multiple sclerosis, cerebrovascular events, myelopathy, encephalomyelitis, etc.), peripheral vascular diseases (arteriosclerosis obliterans, diabetic angiopathy, thrombangiitis obliterans, Raynaud's disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittent), Little's diseases and other encephalopathies accompanied by dystonia.
- •Patients suffering from myasthenia gravis or myopathies with muscle weakness as the prominent symptom.
- •Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
- •Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •Pregnant and lactating females.
- •Simultaneous participation in another clinical study.
结局指标
主要结局
Pain intensity (recorded on VAS), tenderness (graded from 0 to 3), joint mobility (recorded on VAS), Spasm relief (recorded on VAS), need for rescue medication. Time needed for the patient to be symptom free.
时间窗: 0, 4 days, 7 days, 14 days, 21 days
次要结局
- Digit / alphabet cancellation test, reaction time : auditory and visual using the reaction time apparatus, flicker fusion frequency using the flicker fusion apparatus, measurement of hand grip strength, ADR recording, blood investigations(0, 21 days)
研究者
研究点 (3)
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