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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Care Provider)
- Study Primary Completion Date: July 2028
- 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
- 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.
- Adverse events
- Time Frame: 16 weeks
- Incidence and severity of adverse events recorded during the study
Participating in This Clinical Trial
- 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
- Lead Sponsor
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Arthur M Kummer, MD, PhD, +551938879851, firstname.lastname@example.org
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