Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery

Last updated: October 11, 2016
Sponsor: Daewon Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Oral Facial Pain

Acute And Chronic Dental Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT01920386
DW 0919 302 Version 1.0
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 fromthe 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

Study Design

Total Participants: 240
Study Start date:
June 01, 2013
Estimated Completion Date: