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

September 5, 2023 updated by: EMS

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Canadá association 1 tablet twice a day
Other: Dipyrone placebo
Placebo of dipyrone 1 tablet twice a day
Other: Tramadol hydrochloride placebo
Placebo of tramadol 1 coated tablet twice a day
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: Dipyrone placebo
Placebo of dipyrone 1 tablet twice a day
Other: Canadá placebo
Placebo of Canadá association 1 tablet twice a day
Drug: Tramadol hydrochloride
Tramadol 1 coated tablet twice a day
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: Tramadol hydrochloride placebo
Placebo of tramadol 1 coated tablet twice a day
Other: Canadá placebo
Placebo of Canadá association 1 tablet twice a day
Drug: Dipyrone
Dipyrone 1 tablet twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in pain intensity assessed by the VAS scale
Time Frame: 12 weeks
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
Time Frame: 16 weeks
Incidence and severity of adverse events recorded during the study
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS1120 - CANADÁ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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