Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients
- Registration Number
- NCT02375633
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pelubiprofen Pelubiprofen Active Comparator(Pelubiprofen) 30mg three times a day DW-330SR2 DW-330SR2 DW-330SR(Pelubiprofen) 45mg twice a day
- Primary Outcome Measures
Name Time Method The change of 100 mm Pain VAS 28 days
- Secondary Outcome Measures
Name Time Method