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

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ClinicalTrials.gov Identifier: NCT01782846
Recruitment Status : Completed
First Posted : February 4, 2013
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

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 or disease Intervention/treatment Phase
Pain Drug: Ixprim® Drug: Dafalgan-Codeine® Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 803 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.
Study Start Date : March 2011
Primary Completion Date : February 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Codeine
U.S. FDA Resources

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®

Primary Outcome Measures :
  1. pain improvement [ Time Frame: 120 minutes ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782846

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

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01782846     History of Changes
Other Study ID Numbers: 2010/45
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 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