NCT01471899已完成3 期
Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
EMS0 个研究点目标入组 78 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 主要终点
- Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain treatment.
详细描述
- double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial.
- Experiment duration: 04 days.
- 03 visits (days 0, 2 and 4).
- Efficacy will be evaluated for back pain relief based on visual analogic scale.
- Adverse events evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent of the patient or legal guardian.
- •Men or women aged between 18 and
- •Diagnosis of acute low back pain with moderate to severe pain (Visual Analogic score greater than 4 cm)
排除标准
- •fracture confirmed by X-ray
- •Diagnosis of infection, fever,
- •Pregnancy, lactation;
- •Diagnosis of fibromyalgia;
- •Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory
研究组 & 干预措施
Naproxen
Active Comparator
2 tablets every 8 hours for 4 days.
干预措施: Naproxen (Drug)
Ketorolac Tromethamine
Experimental
10 drops every 8 hours for 4 days
干预措施: Ketorolac Tromethamine (Drug)
结局指标
主要结局
Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).
时间窗: 4 days
The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit. The response rate is calculated using the following formula: Response rate = (VASvi - VASvf) / VASvi Considering: * VASvi: VAS in the first visit; * VASvf: VAS at the last visit;
次要结局
- Safety will be evaluated by the adverse events occurrences(day 4)
研究者
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