Trama-Code (Two Analgesics-comparative Study) (Trama-Code)

April 19, 2016 updated by: Hopital Foch

Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.

Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.

The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

803

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • France
    • Ile de France
      • Suresnes, Ile de France, France, 92150
        • Hôpital FOCH - Emergency unit

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of 18 - 75 years of age
  • Presented to the emergency unit of FOCH hospital
  • Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse

Exclusion Criteria:

  • Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours
  • pregnant or lactating females
  • Patient with one or more contraindication to one of the study drugs
  • Patients for whom the pain assessment scale can not be performed (unconscious, confused ...)
  • Patient cannot be included for legal reasons
  • Patient required urgent management
  • Patient for whom it is considered difficult to be reassessed 2 hours later
  • Patient unable to swallow

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
Active Comparator: Ixprim®
2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol)
Drug: Ixprim®
Active Comparator: Dafalgan Codeine®
Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine)
Drug: Dafalgan-Codeine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain improvement
Time Frame: 120 minutes
120 minutes

Collaborators and Investigators

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

Sponsor

Hopital Foch

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

March 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/45

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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