Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Low Back Pain

Treatments: Drug: Tramadol hydrochloride/Acetaminophen SR Tab.; Drug: Tramadol hydrochloride/Acetaminophen Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01776515

DW 0919 301 Version 1.00

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult males/Females aged over 20 years
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

1. Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension
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

Trial design

0 participants in 2 patient groups

Tramadol hydrochloride/Acetaminophen Tab.

Active Comparator group

Treatment:

Drug: Tramadol hydrochloride/Acetaminophen Tab.

Tramadol hydrochloride/Acetaminophen SR Tab.

Experimental group

Treatment:

Drug: Tramadol hydrochloride/Acetaminophen SR Tab.