CTRI/2011/10/002074已完成3 期
Comparative,Randomized Parallel group,Multicentric Prospective Phase III Clinical trial of FDC of Tolperisone Hcl SR 450mg+ Diclofenac sodium SR100mg tablet OD compared with Tolperisone Hcl 150mg tablet TID for 7 Days in Patients Suffering with Acute Non Specific Low Back Pain. - NI
Inventia Health care Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorder.,
- •Low back pain 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.
- •Widespread neurological symptoms (including Cauda equine syndrome).
- •Structural deformity.
- •Clinical significant renal dysfunction defined by Creatinine 1.5µmol/L.
- •Clinically significant hepatic dysfunction defined by:
- •Total Bilirubin 2 µmol/L.
- •SGOT (AST) 1.5 U/L.
- •SGPT (ALT) 1.5 U/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.
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