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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

Daewon Pharmaceutical logo

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

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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