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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Average pain within the last 24 hours (VAS -I) at Day 1 (before starting treatment), Day 3 & Day 8
研究概览
简要总结
It is an openlabelled, multicentre, randomized, comparative clinical phase III trial whichis going to compare the Efficacy and Safety of Test Product: Thiocolchicoside Oral Spray withReference Product Myoril 8 mg capsules inpatients with Acute Non Specific Low Back Pain. Total 220 patients (includinganticipated dropout of about 10%) will be recruited from three investigationalsites of India. The patients recruited into the study will receiveeither two squirts of Thiocolchicoside Oral Spray two times a day or one Myoril8 mg capsule two times a day as per randomization sheet for 7 consecutive days. The primary efficacycriterion will be measured as Average pain within the last 24 hours (VAS -I) atDay 1 (before starting treatment), Day 3 & Day 8. While secondary efficacycriteria will be measured as Pain on movement (VAS - II) at D1, D3 and D8;Stiffness (Hand to- floor distance) at D1, D3 and D8; Disability (Roland Morrisquestionnaire) at D1, D3 and D8; Patient perceived change after treatment (GlobalPerceived Effect , GPE) at D8.Safetyassessment will be done in terms of spontaneously reported and directlyobserved adverse events (AEs) after administered dose until post treatmentfollow up and suspected side effects observed throughout study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with either sex with the age between 16 and 70 years.
- •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).
- •Ability to understand and comply with protocol requirements.
- •Patients who have signed and dated their written informed consent prior to initial of the study.
- •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.
排除标准
- •Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
- •Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
- •Positive history of cerebro-vascular accidents
- •Patients treated during two days prior to inclusion with steroidal agents.
- •Known or suspected hypersensitivity to thiocolchicoside.
- •Concomitant treatment with 2-agonists (i.e. clonidine).
- •Pregnant or breast feeding women.
- •Females of child bearing potential, not taking adequate contraception.
- •Patients with history of alcohol, drugs or narcotics abuse.
结局指标
主要结局
Average pain within the last 24 hours (VAS -I) at Day 1 (before starting treatment), Day 3 & Day 8
时间窗: at Day 1 (before starting treatment), Day 3 & Day 8
次要结局
- -Pain on movement (VAS - II) at D1, D3 and D8(-Stiffness (Hand-to-floor distance) at D1, D3 and D8)