Trama-Code (Two Analgesics-comparative Study) | NCT01782846

Studies
Trama-Code (Two Analgesics-comparative Study)

NCT01782846

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Apr 20, 2016Estimated

Enrollment

803Actual

Phase

Phase 4

Conditions

Pain

Interventions

Ixprim®
Dafalgan-Codeine®

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jan 25, 2013

First Submission Date that Met QC Criteria

Jan 31, 2013

First Posted Date

Feb 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

803Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ixprim®	Drug		Ixprim®
Dafalgan-Codeine®

Measure	Description	Time Frame
pain improvement		120 minutes

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital FOCH - Emergency unit		Suresnes	Île-de-France Region	92150	France

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Not provided

Browse Branches

Not provided