NCT01782846

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
803

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Mar 2011

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

January 25, 2013

Last Update Submit

April 19, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • pain improvement

    120 minutes

Study Arms (2)

Ixprim®

ACTIVE COMPARATOR

2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol)

Drug: Ixprim®

Dafalgan Codeine®

ACTIVE COMPARATOR

Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine)

Drug: Dafalgan-Codeine®

Interventions

Ixprim®DRUG
Ixprim®
Dafalgan-Codeine®DRUG
Dafalgan Codeine®

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH - Emergency unit

Suresnes, Île-de-France Region, 92150, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

February 4, 2013

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

FR(1)