CTRI/2010/091/001412已完成3 期
Comparative, Randomized, Double Blind, Parallel, Multicentric Study for Efficacy and Safety of Tapentadol Versus Tramadol In the Management of Acute Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- •1.Male or female patients
- •2.Age between 20-65 years
- •3.Willing to give written informed consent and willing to comply with study protocol.
- •4.Patients with acute or relapsing LBP moderate to severe intensity.
- •5.Patients with at least 40 mm pain intensity on VAS scale
- •6.Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
- •7.Patients not on any anti-inflammatory or other therapy for the past 2 weeks known to affect the study outcome.
排除标准
- •1.Pregnant and lactating women
- •2.Patients with H/O any drug allergy
- •3.Severe spinal disease like spondylitis, fractures, cancer, severe arthrosis and osteoporosis.
- •4.Muscle diseases such as myositis, polymyositis, muscular dystrophy and myotony.
- •5.Unwilling to comply with the protocol requirements
- •6.H/o skin lesions, skin ulcers.
- •7.Patients with gastro-intestinal disease, peptic ulcer, bleeding disorder and faecal blood loss
- •8.Patients with cardiac, hepatic and renal dysfunction and haemopoetic disorder
- •9.Patients with hypertension
- •10.Patients deemed ineligible by the investigator
研究者
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