Pain, Chronic
Conditions
Keywords
Analgesia, Pain Management
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Canadá association in the treatment of chronic pain
Interventions
DRUGCanadá
Canadá association 1 tablet twice a day
OTHERCanadá placebo
Placebo of Canadá association 1 tablet twice a day
DRUGDipyrone
Dipyrone 1 tablet twice a day
OTHERDipyrone placebo
Placebo of dipyrone 1 tablet twice a day
DRUGTramadol hydrochloride
Tramadol 1 coated tablet twice a day
OTHERTramadol hydrochloride placebo
Placebo of tramadol 1 coated tablet twice a day
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in pain intensity assessed by the VAS scale | 12 weeks | Change from baseline in the pain intensity escores assessed in medical visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 16 weeks | Incidence and severity of adverse events recorded during the study |
Outcome results
None listed