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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776515

Enrollment

Unknown

Registered

2013-01-28

Start date

2012-01-31

Completion date

2012-06-30

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low back pain, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen

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.

Interventions

DRUGTramadol hydrochloride/Acetaminophen Tab.

DRUGTramadol hydrochloride/Acetaminophen SR Tab.

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Changes in '100 mm pain VAS' value from baseline	0, 1, 7, 14, 28 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026