Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain (CANADÁ)

EMS

Status and phase: Withdrawn; Phase 2

Conditions: Pain, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05125978

EMS1120 - CANADÁ

Details and patient eligibility

About

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

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Canadá association

Experimental group

Description:

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.

Treatment:

Other: Tramadol hydrochloride placebo

Drug: Canadá

Other: Dipyrone placebo

Tramadol

Active Comparator group

Description:

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.

Treatment:

Other: Canadá placebo

Other: Dipyrone placebo

Drug: Tramadol hydrochloride

Dipyrone

Active Comparator group

Description:

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.

Treatment:

Other: Tramadol hydrochloride placebo

Other: Canadá placebo

Drug: Dipyrone