Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients

October 7, 2016 updated by: Daewon Pharmaceutical Co., Ltd.
A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
  • Class 1 or 2 back pain patients along Quebec Task Force Classification
  • Patients with pain at least 40mm test results at visit2
  • The voluntary or legal guardian 's written consent to participate in this clinical trial subjects

Exclusion Criteria:

  • Severe gastrointestinal disease, heart disease, high blood pressure patients
  • Patients with secondary causes are obvious
  • Within 24 weeks patient who has back surgery before clinical trial participation
  • Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
  • Within 4 weeks patient who treated steroid drug by oral or injection
  • Within 2 weeks patient who treated MAO inhibition drugs
  • Patients with severe respiratory depression status

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DW-330SR2
DW-330SR(Pelubiprofen) 45mg twice a day
Drug: DW-330SR2
Active Comparator: Pelubiprofen
Active Comparator(Pelubiprofen) 30mg three times a day
Drug: Pelubiprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of 100 mm Pain VAS
Time Frame: 28 days
28 days

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

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW-330SR2_301

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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