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

NCT04666701 | Withdrawn Phase 2 DMC

• 1 other identifier: EMS1319 - ESCÓCIA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence and severity of adverse events recorded during the study

  10 days

Study Arms (3)

Escócia association

EXPERIMENTAL

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; Other: Placebo Ketorolac; Other: Placebo Scopolamine

Ketorolac

ACTIVE COMPARATOR

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; Drug: Ketorolac Tromethamine; Other: Placebo Escócia association

Scopolamine

ACTIVE COMPARATOR

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; Drug: Scopolamine; Other: Placebo Escócia association

Interventions

Escócia association DRUG

Escócia association tablet

Escócia association

Placebo Ketorolac OTHER

Placebo Ketorolac tablet

Escócia association; Scopolamine

Placebo Scopolamine OTHER

Placebo Scopolamine dragee

Escócia association; Ketorolac

Ketorolac Tromethamine DRUG

Ketorolac tablet

Ketorolac

Scopolamine DRUG

Scopolamine dragee

Scopolamine

Placebo Escócia association OTHER

Placebo Escócia association tablet

Ketorolac; Scopolamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Ketorolac Tromethamine; Scopolamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share