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

October 11, 2016 updated by: Daewon Pharmaceutical Co., Ltd.

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 After Teeth Extraction Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.
1tab PO within 5hours from teeth extraction
Drug: Tramadol hydrochloride/Acetaminophen Tab.
Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.
1tab PO within 5hours from teeth extraction and then 1tab more after 6hours
Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SPID ; Sum of the pain intensity differences
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 12, 2013

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW 0919 302 Version 1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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