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WithdrawnNCT05125978CANADÁUpdated Sep 8, 2023

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

A Phase 2 interventional study of Canadá and Canadá placebo in Pain, Chronic, sponsored by EMS. Withdrawn. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by EMS · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Strategy review
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pain, Chronic

Browse trials for

Keywords

  • Analgesia
  • Pain Management
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

Browse Chronic Pain studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • 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.

    Drug: Canadá · Other: Dipyrone placebo · Other: Tramadol hydrochloride placebo

  • 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.

    Other: Canadá placebo · Other: Dipyrone placebo · Drug: Tramadol hydrochloride

  • 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.

    Other: Canadá placebo · Drug: Dipyrone · Other: Tramadol hydrochloride placebo

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

06

What researchers measure

Primary outcomes

  1. Difference in pain intensity assessed by the VAS scale

    Change from baseline in the pain intensity escores assessed in medical visits.

    Time frame: 12 weeks

Secondary outcomes

  1. Adverse events

    Incidence and severity of adverse events recorded during the study

    Time frame: 16 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05125978
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Nov 18, 2021
Start date
Sep 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 8, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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