Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
Information source: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
Intervention: Tramadol hydrochloride/Acetaminophen Tab. (Drug); Tramadol hydrochloride/Acetaminophen SR Tab. (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daewon Pharmaceutical Co., Ltd.
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.
Clinical Details
Official title: 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 After Teeth Extraction Surgery
Study design: N/A
Primary outcome: SPID ; Sum of the pain intensity differences
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Last updated: January 13, 2014
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