A clinical study to compare efficacy and safety of test product Thiocolchicoside OralSpray with Reference Product Myoril 8 mg capsules in patients with Acute Non Specific Low Back Pain

incoln Pharmaceuticals Ltd0 个研究点目标入组 220 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Patient with either sex with the age between 16 and 70 years.
•2. Non specific low back pain with an acute episode of recent onset ( <48 hours) defined by average pain within the last 24 hours on the Visual Analogue Scale (VAS).
•3. Ability to understand and comply with protocol requirements.
•4. Patients who have signed and dated their written informed consent prior to initial of the study.
•5. Low back pain of diagnosis category 1 (low back pain radiating no further than the knee), as defined by the International Paris Task Force on Back Pain.

•1. Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
•2. Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
•3. Positive history of cerebro-vascular accidents
•4. Patients treated during two days prior to inclusion with steroidal agents.
•5. Known or suspected hypersensitivity to thiocolchicoside.
•6. Concomitant treatment with 2-agonists (i.e. clonidine).
•7. Pregnant or breast feeding women.
•8. Females of child bearing potential, not taking adequate contraception.
•9. Patients with history of alcohol, drugs or narcotics abuse.

发起方

incoln Pharmaceuticals Ltd