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OpenTrials
Completed

NCT Number: NCT01776515

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol hydrochloride/Acetaminophen Tab.

Drug

Tramadol hydrochloride/Acetaminophen SR Tab.

Drug

Primary outcomes

  1. Changes in '100 mm pain VAS' value from baseline

    Time frame: 0, 1, 7, 14, 28 day

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2013
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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