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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02375633
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : October 10, 2016
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Back Pain Drug: DW-330SR2 Drug: Pelubiprofen Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2014
Actual Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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

Primary Outcome Measures :
  1. The change of 100 mm Pain VAS [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Daewon Pharmaceutical Co., Ltd. Identifier: NCT02375633     History of Changes
Other Study ID Numbers: DW-330SR2_301
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Back Pain
Neurologic Manifestations
Signs and Symptoms