Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
Phase 1
Completed
- Conditions
- Low Back Pain
- Interventions
- Registration Number
- NCT01776515
- Lead Sponsor
- Daewon Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult males/Females aged over 20 years
- Patient with low back pain who needs analgesic administration
- Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification
- Pain VAS Value over 40 mm
- Subjects who voluntarily or legal guardian agreed with written consent
Exclusion Criteria
- Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension
- Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease)
- Patients who had taken back surgery within 24 weeks from the screening point
- Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point
- Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tramadol hydrochloride/Acetaminophen Tab. Tramadol hydrochloride/Acetaminophen Tab. - Tramadol hydrochloride/Acetaminophen SR Tab. Tramadol hydrochloride/Acetaminophen SR Tab. -
- Primary Outcome Measures
Name Time Method Changes in '100 mm pain VAS' value from baseline 0, 1, 7, 14, 28 day
- Secondary Outcome Measures
Name Time Method