NCT01776515
Completed
Phase 1
A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
ConditionsLow Back Pain
Overview
- Phase
- Phase 1
- Intervention
- Tramadol hydrochloride/Acetaminophen Tab.
- Conditions
- Low Back Pain
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
- Primary Endpoint
- Changes in '100 mm pain VAS' value from baseline
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Tramadol hydrochloride/Acetaminophen Tab.
Intervention: Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.
Intervention: Tramadol hydrochloride/Acetaminophen SR Tab.
Outcomes
Primary Outcomes
Changes in '100 mm pain VAS' value from baseline
Time Frame: 0, 1, 7, 14, 28 day
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