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

NCT ID: NCT05125978

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-30

Study Completion Date

2028-07-31

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

Detailed Description

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Conditions

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Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Canadá

Intervention Type DRUG

Canadá association 1 tablet twice a day

Dipyrone placebo

Intervention Type OTHER

Placebo of dipyrone 1 tablet twice a day

Tramadol hydrochloride placebo

Intervention Type OTHER

Placebo of tramadol 1 coated tablet twice a day

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.

Group Type ACTIVE_COMPARATOR

Canadá placebo

Intervention Type OTHER

Placebo of Canadá association 1 tablet twice a day

Dipyrone placebo

Intervention Type OTHER

Placebo of dipyrone 1 tablet twice a day

Tramadol hydrochloride

Intervention Type DRUG

Tramadol 1 coated tablet twice a day

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.

Group Type ACTIVE_COMPARATOR

Canadá placebo

Intervention Type OTHER

Placebo of Canadá association 1 tablet twice a day

Dipyrone

Intervention Type DRUG

Dipyrone 1 tablet twice a day

Tramadol hydrochloride placebo

Intervention Type OTHER

Placebo of tramadol 1 coated tablet twice a day

Interventions

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Canadá

Canadá association 1 tablet twice a day

Intervention Type DRUG

Canadá placebo

Placebo of Canadá association 1 tablet twice a day

Intervention Type OTHER

Dipyrone

Dipyrone 1 tablet twice a day

Intervention Type DRUG

Dipyrone placebo

Placebo of dipyrone 1 tablet twice a day

Intervention Type OTHER

Tramadol hydrochloride

Tramadol 1 coated tablet twice a day

Intervention Type DRUG

Tramadol hydrochloride placebo

Placebo of tramadol 1 coated tablet twice a day

Intervention Type OTHER

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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EMS1120 - CANADÁ

Identifier Type: -

Identifier Source: org_study_id

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