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

Overview

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

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Care Provider)
• Study Primary Completion Date: July 2028

Interventions

• 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

Arms, Groups and Cohorts

• Experimental: Canadá association
  • 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.
• Active Comparator: Tramadol
  • 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.
• Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

• Difference in pain intensity assessed by the VAS scale
  • Time Frame: 12 weeks
  • Change from baseline in the pain intensity escores assessed in medical visits.

Secondary Measures

• Adverse events
  • Time Frame: 16 weeks
  • Incidence and severity of adverse events recorded during the study

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • EMS
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Contact(s)
  • Arthur M Kummer, MD, PhD, +551938879851, pesquisa.clinica@ncfarma.com.br