Status:
COMPLETED
Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Conditions:
Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. \& Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patie...
Eligibility Criteria
Inclusion
- Adult males/Females aged over 20 years
- Patients with over 2 impacted wisdom teeth in the upper and lower jaws
- Pain VAS Value over 50 mm evaluated as 100mm VAS
- Subjects who voluntarily or legal guardian agreed with written consent
Exclusion
- Patients with severe heart disease, uncontrol hypertension, diabetes
- Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point
- Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)
- Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history
- Patients with severe respiratory depression
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01920386
Start Date
June 1 2013
Last Update
October 12 2016
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