Acute PainPhase 2NCT04666701

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

A Phase 2 study testing Escócia association, Ketorolac Tromethamine and Scopolamine in people with Acute Pain, run by EMS.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Pain
What is being tested?: Escócia association, Ketorolac Tromethamine and Scopolamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Feb 2023to Jun 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

About this study

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

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

Conditions: Acute Pain
Being tested: Escócia association, Placebo Ketorolac, Placebo Scopolamine, Ketorolac Tromethamine, Scopolamine
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Escócia associationDrug
Escócia association tablet
Placebo KetorolacOther
Placebo Ketorolac tablet
Placebo ScopolamineOther
Placebo Scopolamine dragee
Ketorolac TromethamineDrug
Ketorolac tablet
ScopolamineDrug
Scopolamine dragee
Placebo Escócia associationOther
Placebo Escócia association tablet

Study groups in NCT04666701
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Other: Placebo Ketorolac; Drug: Scopolamine; Other: Placebo Escócia association

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0-1 hour

Secondary outcomes (1)

Incidence and severity of adverse events recorded during the study
Incidence and severity of adverse events recorded during the study over 10 days.
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2023Jun 2025

First posted14 Dec 2020
Study startFeb 2023 (estimated)
Primary completionFeb 2025 (estimated)
Study completionJun 2025 (estimated)

Why it stopped: Strategy review

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute PainStudies of the same condition, open and under way.
More trials run by EMSThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04666701
Sponsor's protocol ID: EMS1319 - ESCÓCIA
Status last verified: Sep 2023
First submitted: 8 Dec 2020
Last updated: 8 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
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A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
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All Acute Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04666701
Acronym / sponsor ID: EMS1319 - ESCÓCIA
Conditions: Acute Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Strategy review
Enrolment: 0 participants (actual)
Lead sponsor: EMSIndustry (pharma, biotech, devices)
Study start: Feb 2023 (estimated)
Primary completion: Feb 2025 (estimated)
Study completion: Jun 2025 (estimated)
First posted: 14 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Escócia association	Experimental	Drug: Escócia association, Other: Placebo Ketorolac, Other: Placebo ScopolamineThe 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
Ketorolac	Active comparator	Other: Placebo Scopolamine, Drug: Ketorolac Tromethamine, Other: Placebo Escócia associationThe 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
Scopolamine	Active comparator	Other: Placebo Ketorolac, Drug: Scopolamine, Other: Placebo Escócia associationThe 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Escócia associationEscócia association tablet	Drug	Escócia association
Placebo KetorolacPlacebo Ketorolac tablet	Other	Escócia association, Scopolamine
Placebo ScopolaminePlacebo Scopolamine dragee	Other	Escócia association, Ketorolac
Ketorolac TromethamineKetorolac tablet	Drug	Ketorolac
ScopolamineScopolamine dragee	Drug	Scopolamine
Placebo Escócia associationPlacebo Escócia association tablet	Other	Ketorolac, Scopolamine

Primary outcome

Change from baseline in pain intensity
Time frame: 0-1 hour
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.

1 secondary outcome

Incidence and severity of adverse events recorded during the study
Time frame: 10 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
Individual participant dataSharing planned: No

Related trials for Acute Pain

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Escócia association, Ketorolac Tromethamine and Scopolamine in people with Acute Pain, run by EMS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in pain intensity (time frame: 0-1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04666701.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.