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

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: January 25, 2013
Last updated: April 19, 2016
Last verified: April 2016

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
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 ]

Enrollment: 803
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: February 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01782846

Hôpital FOCH - Emergency unit
Suresnes, Ile de France, France, 92150
Sponsors and Collaborators
Hopital Foch
  More Information

Responsible Party: Hopital Foch Identifier: NCT01782846     History of Changes
Other Study ID Numbers: 2010/45
Study First Received: January 25, 2013
Last Updated: April 19, 2016

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents processed this record on August 16, 2017