Status:
WITHDRAWN
Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
Lead Sponsor:
EMS
Conditions:
Acute Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04666701
Start Date
February 1 2023
End Date
June 1 2025
Last Update
September 8 2023
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