Efficacy and Safety of Escócia Association in the Treatme... | NCT04666701

NCT04666701

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Escócia association	Drug	Escócia association tablet	Escócia association

Outcomes Module

Primary Outcomes

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

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

Eligibility Module

Eligibility Criteria

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.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D020911	Ketorolac Tromethamine
D012601	Scopolamine

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring