Back to resultsEfficacy and Safety of Escócia Association in the Treatment of Acute Pain
Primary Purpose
Acute Pain
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Escócia association
Placebo Ketorolac
Placebo Scopolamine
Ketorolac Tromethamine
Scopolamine
Placebo Escócia association
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Escócia association
Ketorolac
Scopolamine
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence and severity of adverse events recorded during the study
Incidence and severity of adverse events recorded during the study over 10 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04666701
Brief Title
Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Strategy review
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escócia association
Arm Type
Experimental
Arm Description
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
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
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
Arm Title
Scopolamine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Escócia association
Intervention Description
Escócia association tablet
Intervention Type
Other
Intervention Name(s)
Placebo Ketorolac
Intervention Description
Placebo Ketorolac tablet
Intervention Type
Other
Intervention Name(s)
Placebo Scopolamine
Intervention Description
Placebo Scopolamine dragee
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Intervention Description
Ketorolac tablet
Intervention Type
Drug
Intervention Name(s)
Scopolamine
Intervention Description
Scopolamine dragee
Intervention Type
Other
Intervention Name(s)
Placebo Escócia association
Intervention Description
Placebo Escócia association tablet
Primary Outcome Measure Information:
Title
Change from baseline in pain intensity
Description
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.
Time Frame
0-1 hour
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study
Description
Incidence and severity of adverse events recorded during the study over 10 days.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
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