Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
Conditions
Keywords
Acute Toothache, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen
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 Patients above Moderate Pain after Teeth Extraction Surgery.
Interventions
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult males/Females aged over 20 years 2. Patients with over 2 impacted wisdom teeth in the upper and lower jaws 3. Pain VAS Value over 50 mm evaluated as 100mm VAS 4. Subjects who voluntarily or legal guardian agreed with written consent
Exclusion criteria
1. Patients with severe heart disease, uncontrol hypertension, diabetes 2. Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point 3. 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) 4. Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history 5. Patients with severe respiratory depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPID ; Sum of the pain intensity differences | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour |
Outcome results
None listed