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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

Page last updated: August 23, 2015

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