Efficacy and Safety of Escócia Association in the Treatment of Acute Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.

Official Title
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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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Escócia association
* Other: Placebo Ketorolac
* Other: Placebo Scopolamine
* Drug: Ketorolac Tromethamine
* Drug: Scopolamine
* Other: Placebo Escócia association


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escócia association<br>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 | Drug: Escócia association<br>* Escócia association tablet<br>Other: Placebo Ketorolac<br>* Placebo Ketorolac tablet<br>Other: Placebo Scopolamine<br>* Placebo Scopolamine dragee<br>|
| Active Comparator: Ketorolac<br>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 | Other: Placebo Scopolamine<br>* Placebo Scopolamine dragee<br>Drug: Ketorolac Tromethamine<br>* Ketorolac tablet<br>Other: Placebo Escócia association<br>* Placebo Escócia association tablet<br>|
| Active Comparator: Scopolamine<br>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 | Other: Placebo Ketorolac<br>* Placebo Ketorolac tablet<br>Drug: Scopolamine<br>* Scopolamine dragee<br>Other: Placebo Escócia association<br>* Placebo Escócia association tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain intensity | 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. | 0-1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study | Incidence and severity of adverse events recorded during the study over 10 days. | 10 days |