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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01776515
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 21, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date January 28, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January¬†23,¬†2013)
Changes in '100 mm pain VAS' value from baseline [ Time Frame: 0, 1, 7, 14, 28 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Not Provided
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Tramadol hydrochloride/Acetaminophen Tab.
  • Drug: Tramadol hydrochloride/Acetaminophen SR Tab.
Study Arms  ICMJE
  • Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.
    Intervention: Drug: Tramadol hydrochloride/Acetaminophen Tab.
  • Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.
    Intervention: Drug: Tramadol hydrochloride/Acetaminophen SR Tab.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776515
Other Study ID Numbers  ICMJE DW 0919 301 Version 1.00
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daewon Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Daewon Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewon Pharmaceutical Co., Ltd.
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP