Trama-Code (Two Analgesics-comparative Study)

This study is currently recruiting participants.
Verified January 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01782846
First received: January 25, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Pain
Drug: Ixprim®
Drug: Dafalgan-Codeine®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Official Title: Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • pain improvement [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: March 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782846

Contacts
Contact: Emmanuel Mathieu, MD +33 1 46252028 e.mathieu@hopital-foch.org

Locations
France
Hôpital FOCH - Emergency unit Recruiting
Suresnes, Ile de France, France, 92150
Contact: Emmanuel Mathieu, MD       e.mathieu@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01782846     History of Changes
Other Study ID Numbers: 2010/45
Study First Received: January 25, 2013
Last Updated: January 31, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Codeine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 23, 2014