National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change from baseline in pain intensity
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute 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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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 informed consent forms;
- •Participants, aged 18 years and older, with renal colic admitted in the emergency service, or those who underwent an extracorporeal lithotripsy procedure to eliminate kidney stones.
排除标准
- •Known hypersensitivity to the formula components used during the clinical trial;
- •History of alcohol and/or substance abuse within 2 years;
- •Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;
- •Participants weighing less than 50 kg;
- •Participants with suspected other causes of acute abdominal pain;
- •Participants with a known history of peptic ulcer, gastrointestinal bleeding, perforation or inflammatory bowel disease;
- •Participants with hypovolemia or dehydration;
- •Renal failure, defined by the estimated glomerular filtration rate [eGFR] <60 mL / min / 1.73 m2;
- •Participants with a known medical history of cerebrovascular bleeding, hemorrhagic diathesis (hemophilia), blood clotting disorders; postoperative of coronary artery bypass graft surgery, or using anticoagulants, including low heparin dose (2500-5000 units every 12 hours);
- •Participants in the postoperative period with a high risk of bleeding or incomplete homeostasis;
- •Participants with cardiovascular disease, chronic heart failure or with increased risk of cardiovascular events are at the discretion of the investigator, in order to include the participant;
- •Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;
- •Participants using pentoxifylline, probenecid or lithium salts;
- •Participants with megacolon and / or paralytic or obstructive ileus;
- •Participants with glaucoma and myasthenia gravis;
- •Participants on treatment with MAO inhibitors, or participants who have been treated with these drugs within 14 days;
- •Participants on epilepsy not adequately controlled treatment.
研究组 & 干预措施
Escócia association
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 tablet Escócia association, oral
1 dragee Placebo Scopolamine, oral
1 tablet Placebo Ketorolac, sublingual
干预措施: Escócia association (Drug)
Escócia association
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 tablet Escócia association, oral
1 dragee Placebo Scopolamine, oral
1 tablet Placebo Ketorolac, sublingual
干预措施: Placebo Ketorolac (Other)
Escócia association
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 tablet Escócia association, oral
1 dragee Placebo Scopolamine, oral
1 tablet Placebo Ketorolac, sublingual
干预措施: Placebo Scopolamine (Other)
Ketorolac
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 tablet Ketorolac, sublingual
1 tablet Placebo Escócia association, oral
1 dragee Placebo Scopolamine, oral
干预措施: Placebo Scopolamine (Other)
Ketorolac
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 tablet Ketorolac, sublingual
1 tablet Placebo Escócia association, oral
1 dragee Placebo Scopolamine, oral
干预措施: Ketorolac Tromethamine (Drug)
Ketorolac
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 tablet Ketorolac, sublingual
1 tablet Placebo Escócia association, oral
1 dragee Placebo Scopolamine, oral
干预措施: Placebo Escócia association (Other)
Scopolamine
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 dragee Scopolamine, oral
1 tablet Placebo Ketorolac, sublingual
1 tablet Placebo Escócia association, oral
干预措施: Placebo Ketorolac (Other)
Scopolamine
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 dragee Scopolamine, oral
1 tablet Placebo Ketorolac, sublingual
1 tablet Placebo Escócia association, oral
干预措施: Scopolamine (Drug)
Scopolamine
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows:
1 dragee Scopolamine, oral
1 tablet Placebo Ketorolac, sublingual
1 tablet Placebo Escócia association, oral
干预措施: Placebo Escócia association (Other)
结局指标
主要结局
Change from baseline in pain intensity
时间窗: 0-1 hour
The change from baseline in pain intensity 1 hour after using the first dose of medication. Pain intensity will be assessed by visual analog scale (VAS), between 0 cm (no pain) and 10 cm (worst pain), recorded in the participant's diary.
次要结局
- Incidence and severity of adverse events recorded during the study(10 days)