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

EMS

Status and phase: Withdrawn; Phase 2

Conditions: Acute Pain

Treatments: Drug: Scopolamine; Drug: Escócia association; Other: Placebo Scopolamine; Drug: Ketorolac Tromethamine; Other: Placebo Escócia association; Other: Placebo Ketorolac

Study type: Interventional

Funder types: Industry

Identifiers

NCT04666701

EMS1319 - ESCÓCIA

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Escócia association

Experimental group

Description:

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

Treatment:

Other: Placebo Ketorolac

Drug: Escócia association

Other: Placebo Scopolamine

Ketorolac

Active Comparator group

Description:

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

Treatment:

Other: Placebo Scopolamine

Drug: Ketorolac Tromethamine

Other: Placebo Escócia association

Scopolamine

Active Comparator group

Description:

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

Treatment:

Other: Placebo Ketorolac

Drug: Scopolamine

Other: Placebo Escócia association