Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
803 participants
INTERVENTIONAL
2011-03-31
2013-04-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ixprim®
2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol)
Ixprim®
Dafalgan Codeine®
Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine)
Dafalgan-Codeine®
Interventions
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Ixprim®
Dafalgan-Codeine®
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Locations
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Hôpital FOCH - Emergency unit
Suresnes, Île-de-France Region, France
Countries
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Other Identifiers
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2010/45
Identifier Type: -
Identifier Source: org_study_id
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