search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Low Back Pain focused on measuring Low back pain, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Tramadol hydrochloride/Acetaminophen Tab.

    Tramadol hydrochloride/Acetaminophen SR Tab.

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes in '100 mm pain VAS' value from baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    January 21, 2013
    Last Updated
    January 23, 2013
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01776515
    Brief Title
    Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daewon Pharmaceutical Co., Ltd.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    Low back pain, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen

    7. Study Design

    Study Phase
    Phase 1

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol hydrochloride/Acetaminophen Tab.
    Arm Type
    Active Comparator
    Arm Title
    Tramadol hydrochloride/Acetaminophen SR Tab.
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol hydrochloride/Acetaminophen Tab.
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol hydrochloride/Acetaminophen SR Tab.
    Primary Outcome Measure Information:
    Title
    Changes in '100 mm pain VAS' value from baseline
    Time Frame
    0, 1, 7, 14, 28 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs