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

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

Official Title
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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

Conditions
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Pain, Chronic

Intervention / Treatment
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* Drug: Canadá
* Other: Canadá placebo
* Drug: Dipyrone
* Other: Dipyrone placebo
* Drug: Tramadol hydrochloride
* Other: Tramadol hydrochloride placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canadá association<br>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. | Drug: Canadá<br>* Canadá association 1 tablet twice a day<br>Other: Dipyrone placebo<br>* Placebo of dipyrone 1 tablet twice a day<br>Other: Tramadol hydrochloride placebo<br>* Placebo of tramadol 1 coated tablet twice a day<br>|
| Active Comparator: Tramadol<br>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. | Other: Canadá placebo<br>* Placebo of Canadá association 1 tablet twice a day<br>Other: Dipyrone placebo<br>* Placebo of dipyrone 1 tablet twice a day<br>Drug: Tramadol hydrochloride<br>* Tramadol 1 coated tablet twice a day<br>|
| Active Comparator: Dipyrone<br>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. | Other: Canadá placebo<br>* Placebo of Canadá association 1 tablet twice a day<br>Drug: Dipyrone<br>* Dipyrone 1 tablet twice a day<br>Other: Tramadol hydrochloride placebo<br>* Placebo of tramadol 1 coated tablet twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain intensity assessed by the VAS scale | Change from baseline in the pain intensity escores assessed in medical visits. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence and severity of adverse events recorded during the study | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Pain Management