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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.
• Treatments: Acetaminophen; Tramadol

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