Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
NCT ID: NCT01776515
Last Updated: 2013-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2012-01-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.
Interventions
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Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.
Eligibility Criteria
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Inclusion Criteria
2. Patient with low back pain who needs analgesic administration
3. Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification
4. Pain VAS Value over 40 mm
5. Subjects who voluntarily or legal guardian agreed with written consent
Exclusion Criteria
2. Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease)
3. Patients who had taken back surgery within 24 weeks from the screening point
4. Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point
5. Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point
20 Years
ALL
No
Sponsors
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Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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DW 0919 301 Version 1.00
Identifier Type: -
Identifier Source: org_study_id
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