Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain

NCT05125978 | Withdrawn Phase 2 DMC

• 1 other identifier: EMS1120 - CANADÁ
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Canadá association in the treatment of chronic pain

Conditions

Pain, Chronic

Keywords

Analgesia; Pain Management

Outcome Measures

Primary Outcomes (1)

• Difference in pain intensity assessed by the VAS scale

  Change from baseline in the pain intensity escores assessed in medical visits.

  12 weeks

Secondary Outcomes (1)

• Adverse events

  16 weeks

Study Arms (3)

Canadá association

EXPERIMENTAL

The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet Canadá, oral; 1 placebo tablet of tramadol, oral; 1 placebo tablet of dipyrone, oral.

Drug: Canadá; Other: Dipyrone placebo; Other: Tramadol hydrochloride placebo

Tramadol

ACTIVE COMPARATOR

The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet tramadol, oral; 1 placebo tablet of Canadá, oral; 1 placebo tablet of dipyrone, oral.

Other: Canadá placebo; Other: Dipyrone placebo; Drug: Tramadol hydrochloride

Dipyrone

ACTIVE COMPARATOR

The study is triple-dummy, thus the patient must take 3 tablets twice a day, as follows: 1 tablet dipyrone, oral; 1 placebo tablet of tramadol, oral; 1 placebo tablet of Canadá, oral.

Other: Canadá placebo; Drug: Dipyrone; Other: Tramadol hydrochloride placebo

Interventions

Canadá DRUG

Canadá association 1 tablet twice a day

Canadá association

Canadá placebo OTHER

Placebo of Canadá association 1 tablet twice a day

Dipyrone; Tramadol

Dipyrone DRUG

Dipyrone 1 tablet twice a day

Dipyrone

Dipyrone placebo OTHER

Placebo of dipyrone 1 tablet twice a day

Canadá association; Tramadol

Tramadol hydrochloride DRUG

Tramadol 1 coated tablet twice a day

Tramadol

Tramadol hydrochloride placebo OTHER

Placebo of tramadol 1 coated tablet twice a day

Canadá association; Dipyrone

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
• Chronic pain during at least 3 months.

You may not qualify if:

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;
• History of alcohol abuse or illicit drug use;
• Participation in a clinical trial in the year prior to this study;
• Pregnancy or risk of pregnacy and lactating participants;
• Known hypersensitivity to any of the formula compounds.

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Chronic Pain; Agnosia

Interventions

Dipyrone; Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 8, 2023

Record last verified: 2023-09