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

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery

Treatments: Drug: Tramadol hydrochloride/Acetaminophen SR Tab.; Drug: Tramadol hydrochloride/Acetaminophen Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01920386

DW 0919 302 Version 1.0

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Tramadol hydrochloride/Acetaminophen Tab.

Active Comparator group

Description:

1tab PO within 5hours from teeth extraction

Treatment:

Drug: Tramadol hydrochloride/Acetaminophen Tab.

Tramadol hydrochloride/Acetaminophen SR Tab.

Experimental group

Description:

1tab PO within 5hours from teeth extraction and then 1tab more after 6hours

Treatment:

Drug: Tramadol hydrochloride/Acetaminophen SR Tab.