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Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain (CANADÁ)

Primary Purpose

Pain, Chronic

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Canadá
Canadá placebo
Dipyrone
Dipyrone placebo
Tramadol hydrochloride
Tramadol hydrochloride placebo
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Analgesia, Pain Management

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Canadá association

    Tramadol

    Dipyrone

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Difference in pain intensity assessed by the VAS scale
    Change from baseline in the pain intensity escores assessed in medical visits.

    Secondary Outcome Measures

    Adverse events
    Incidence and severity of adverse events recorded during the study

    Full Information

    First Posted
    November 8, 2021
    Last Updated
    September 5, 2023
    Sponsor
    EMS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05125978
    Brief Title
    Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain
    Acronym
    CANADÁ
    Official Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Strategy review
    Study Start Date
    September 2026 (Anticipated)
    Primary Completion Date
    July 2028 (Anticipated)
    Study Completion Date
    July 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Chronic
    Keywords
    Analgesia, Pain Management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Canadá association
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Tramadol
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Dipyrone
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Canadá
    Intervention Description
    Canadá association 1 tablet twice a day
    Intervention Type
    Other
    Intervention Name(s)
    Canadá placebo
    Intervention Description
    Placebo of Canadá association 1 tablet twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Dipyrone
    Intervention Description
    Dipyrone 1 tablet twice a day
    Intervention Type
    Other
    Intervention Name(s)
    Dipyrone placebo
    Intervention Description
    Placebo of dipyrone 1 tablet twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol hydrochloride
    Intervention Description
    Tramadol 1 coated tablet twice a day
    Intervention Type
    Other
    Intervention Name(s)
    Tramadol hydrochloride placebo
    Intervention Description
    Placebo of tramadol 1 coated tablet twice a day
    Primary Outcome Measure Information:
    Title
    Difference in pain intensity assessed by the VAS scale
    Description
    Change from baseline in the pain intensity escores assessed in medical visits.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Adverse events
    Description
    Incidence and severity of adverse events recorded during the study
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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