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

Phase 2

Withdrawn

• Conditions: Pain, Chronic
• Interventions: Other: Canadá placebo; Drug: Canadá; Other: Dipyrone placebo; Drug: Dipyrone; Other: Tramadol hydrochloride placebo; Drug: Tramadol hydrochloride

• Registration Number: NCT05125978
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-08
• Study Start: 2026-09
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canadá association	Dipyrone placebo	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.
Canadá association	Tramadol hydrochloride placebo	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.
Tramadol	Canadá placebo	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.
Tramadol	Dipyrone placebo	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.
Tramadol	Tramadol hydrochloride	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.
Dipyrone	Canadá placebo	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.
Dipyrone	Dipyrone	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.
Dipyrone	Tramadol hydrochloride placebo	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.
Canadá association	Canadá	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.

Primary Outcome Measures

Name	Time	Method
Difference in pain intensity assessed by the VAS scale	12 weeks	Change from baseline in the pain intensity escores assessed in medical visits.

Secondary Outcome Measures

Name	Time	Method
Adverse events	16 weeks	Incidence and severity of adverse events recorded during the study