Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
NCT ID: NCT04666701
Last Updated: 2023-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-02-28
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Escócia association
Escócia association tablet
Placebo Ketorolac
Placebo Ketorolac tablet
Placebo Scopolamine
Placebo Scopolamine dragee
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
Placebo Scopolamine
Placebo Scopolamine dragee
Ketorolac Tromethamine
Ketorolac tablet
Placebo Escócia association
Placebo Escócia association tablet
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
Placebo Ketorolac
Placebo Ketorolac tablet
Scopolamine
Scopolamine dragee
Placebo Escócia association
Placebo Escócia association tablet
Interventions
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Escócia association
Escócia association tablet
Placebo Ketorolac
Placebo Ketorolac tablet
Placebo Scopolamine
Placebo Scopolamine dragee
Ketorolac Tromethamine
Ketorolac tablet
Scopolamine
Scopolamine dragee
Placebo Escócia association
Placebo Escócia association tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Other Identifiers
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EMS1319 - ESCÓCIA
Identifier Type: -
Identifier Source: org_study_id
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