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

Phase 3

Completed

• Conditions: Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
• Interventions: Drug: Tramadol hydrochloride/Acetaminophen Tab.; Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

• Registration Number: NCT01920386
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-12
• Primary Completion: 2013-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol hydrochloride/Acetaminophen Tab.	Tramadol hydrochloride/Acetaminophen Tab.	1tab PO within 5hours from teeth extraction
Tramadol hydrochloride/Acetaminophen SR Tab.	Tramadol hydrochloride/Acetaminophen SR Tab.	1tab PO within 5hours from teeth extraction and then 1tab more after 6hours

Primary Outcome Measures

Name	Time	Method
SPID ; Sum of the pain intensity differences	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour