Trama-Code (Two Analgesics-comparative Study)

Pain Clinical Trial

— Trama-Code  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782846
• Other study ID #: 2010/45
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2013
• Last updated: April 19, 2016
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ixprim®

• Dafalgan-Codeine®

Locations

Country	Name	City	State
France	Hôpital FOCH - Emergency unit	Suresnes	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain improvement		120 minutes	No