CompletedInterventionalPhase 3Updated Dec 15, 2025
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients | NCT02375633 | Trialant
CompletedInterventionalPhase 3Updated Oct 10, 2016
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients
ClinicalTrials.gov ID
NCT02375633
Lead Sponsor
Daewon Pharmaceutical Co., Ltd.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
166Actual
Last Update Posted
Oct 10, 2016Estimated
Start Date
Apr 2014
Primary Completion Date
Nov 2014Actual
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.
Chronic Back Pain
DW-330SR2
Pelubiprofen
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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