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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05125978
Other study ID # EMS1120 - CANADÁ
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date September 2026
Est. completion date July 2028

Study information

Verified date September 2023
Source EMS
Contact n/a
Is FDA regulated No
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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