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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04666701
• Other study ID #: EMS1319 - ESCÓCIA
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Escócia association
Escócia association tablet

Other:
• Placebo Ketorolac
Placebo Ketorolac tablet
• Placebo Scopolamine
Placebo Scopolamine dragee

Drug:
• Ketorolac Tromethamine
Ketorolac tablet
• Scopolamine
Scopolamine dragee

Other:
• Placebo Escócia association
Placebo Escócia association tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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