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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01776515
First received: January 21, 2013
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Drug: Tramadol hydrochloride/Acetaminophen Tab.
Drug: Tramadol hydrochloride/Acetaminophen SR Tab.
Phase 1

Study Type: Interventional
Official 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

Resource links provided by NLM:


Further study details as provided by Daewon Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Changes in '100 mm pain VAS' value from baseline [ Time Frame: 0, 1, 7, 14, 28 day ]

Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tramadol hydrochloride/Acetaminophen Tab. Drug: Tramadol hydrochloride/Acetaminophen Tab.
Experimental: Tramadol hydrochloride/Acetaminophen SR Tab. Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01776515     History of Changes
Other Study ID Numbers: DW 0919 301 Version 1.00
Study First Received: January 21, 2013
Last Updated: January 23, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Daewon Pharmaceutical Co., Ltd.:
Low back pain
Wontran
Wontran SR Tab.
Tramadol Hydrochloride/Acetaminophen

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 30, 2014