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

Pain, Chronic Clinical Trial

— CANADÁ  

Official title:

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05125978
• Other study ID #: EMS1120 - CANADÁ
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2026
• Est. completion date: July 2028

Study information

• Verified date: September 2023
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Drug:
• Canadá
Canadá association 1 tablet twice a day

Other:
• Canadá placebo
Placebo of Canadá association 1 tablet twice a day

Drug:
• Dipyrone
Dipyrone 1 tablet twice a day

Other:
• Dipyrone placebo
Placebo of dipyrone 1 tablet twice a day

Drug:
• Tramadol hydrochloride
Tramadol 1 coated tablet twice a day

Other:
• Tramadol hydrochloride placebo
Placebo of tramadol 1 coated tablet twice a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in pain intensity assessed by the VAS scale	Change from baseline in the pain intensity escores assessed in medical visits.	12 weeks
Secondary	Adverse events	Incidence and severity of adverse events recorded during the study	16 weeks