National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Difference in pain intensity assessed by the VAS scale
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Canadá association in the treatment of chronic pain
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
- •Chronic pain during at least 3 months.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;
- •History of alcohol abuse or illicit drug use;
- •Participation in a clinical trial in the year prior to this study;
- •Pregnancy or risk of pregnacy and lactating participants;
- •Known hypersensitivity to any of the formula compounds.
研究组 & 干预措施
Canadá association
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet Canadá, oral;
1 placebo tablet of tramadol, oral;
1 placebo tablet of dipyrone, oral.
干预措施: Canadá (Drug)
Canadá association
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet Canadá, oral;
1 placebo tablet of tramadol, oral;
1 placebo tablet of dipyrone, oral.
干预措施: Dipyrone placebo (Other)
Canadá association
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet Canadá, oral;
1 placebo tablet of tramadol, oral;
1 placebo tablet of dipyrone, oral.
干预措施: Tramadol hydrochloride placebo (Other)
Tramadol
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet tramadol, oral;
1 placebo tablet of Canadá, oral;
1 placebo tablet of dipyrone, oral.
干预措施: Canadá placebo (Other)
Tramadol
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet tramadol, oral;
1 placebo tablet of Canadá, oral;
1 placebo tablet of dipyrone, oral.
干预措施: Dipyrone placebo (Other)
Tramadol
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet tramadol, oral;
1 placebo tablet of Canadá, oral;
1 placebo tablet of dipyrone, oral.
干预措施: Tramadol hydrochloride (Drug)
Dipyrone
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet dipyrone, oral;
1 placebo tablet of tramadol, oral;
1 placebo tablet of Canadá, oral.
干预措施: Canadá placebo (Other)
Dipyrone
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet dipyrone, oral;
1 placebo tablet of tramadol, oral;
1 placebo tablet of Canadá, oral.
干预措施: Dipyrone (Drug)
Dipyrone
The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows:
1 tablet dipyrone, oral;
1 placebo tablet of tramadol, oral;
1 placebo tablet of Canadá, oral.
干预措施: Tramadol hydrochloride placebo (Other)
结局指标
主要结局
Difference in pain intensity assessed by the VAS scale
时间窗: 12 weeks
Change from baseline in the pain intensity escores assessed in medical visits.
次要结局
- Adverse events(16 weeks)