Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

January 23, 2013 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 Low Back Pain Patients

The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

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

20 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. Patient with low back pain who needs analgesic administration
  3. Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification
  4. Pain VAS Value over 40 mm
  5. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

  1. Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension
  2. Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease)
  3. Patients who had taken back surgery within 24 weeks from the screening point
  4. Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point
  5. Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point

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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.
Drug: Tramadol hydrochloride/Acetaminophen Tab.
Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.
Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in '100 mm pain VAS' value from baseline
Time Frame: 0, 1, 7, 14, 28 day
0, 1, 7, 14, 28 day

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

January 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW 0919 301 Version 1.00

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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