Trama-Code (Two Analgesics-comparative Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Hopital Foch.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: January 25, 2013
Last updated: January 31, 2013
Last verified: January 2013

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
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®


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01782846

Contact: Emmanuel Mathieu, MD +33 1 46252028

Hôpital FOCH - Emergency unit Recruiting
Suresnes, Ile de France, France, 92150
Contact: Emmanuel Mathieu, MD   
Sponsors and Collaborators
Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch 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:
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses processed this record on December 01, 2015