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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Escócia association; Other: Placebo Ketorolac; Other: Placebo Scopolamine; Drug: Ketorolac Tromethamine; Other: Placebo Escócia association; Drug: Scopolamine

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Escócia association; Escócia association tablet; Other: Placebo Ketorolac; Placebo Ketorolac tablet; Other: Placebo Scopolamine; Placebo Scopolamine dragee
Active Comparator: 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	Other: Placebo Scopolamine; Placebo Scopolamine dragee; Drug: Ketorolac Tromethamine; Ketorolac tablet; Other: Placebo Escócia association; Placebo Escócia association tablet
Active Comparator: 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	Other: Placebo Ketorolac; Placebo Ketorolac tablet; Other: Placebo Escócia association; Placebo Escócia association tablet; Drug: Scopolamine; Scopolamine dragee

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Ketorolac; Ketorolac Tromethamine; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: EMS1319 - ESCÓCIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No