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Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery

Primary Purpose

Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery

Status
Completed
Phase
Phase 3
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 treatment trial for Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery focused on measuring Acute Toothache, 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. Patients with over 2 impacted wisdom teeth in the upper and lower jaws
  3. Pain VAS Value over 50 mm evaluated as 100mm VAS
  4. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

  1. Patients with severe heart disease, uncontrol hypertension, diabetes
  2. Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point
  3. Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)
  4. Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history
  5. Patients with severe respiratory depression

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

    1tab PO within 5hours from teeth extraction

    1tab PO within 5hours from teeth extraction and then 1tab more after 6hours

    Outcomes

    Primary Outcome Measures

    SPID ; Sum of the pain intensity differences

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2013
    Last Updated
    October 11, 2016
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01920386
    Brief Title
    Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
    Official Title
    A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
    Keywords
    Acute Toothache, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    240 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol hydrochloride/Acetaminophen Tab.
    Arm Type
    Active Comparator
    Arm Description
    1tab PO within 5hours from teeth extraction
    Arm Title
    Tramadol hydrochloride/Acetaminophen SR Tab.
    Arm Type
    Experimental
    Arm Description
    1tab PO within 5hours from teeth extraction and then 1tab more after 6hours
    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
    SPID ; Sum of the pain intensity differences
    Time Frame
    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour

    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 Patients with over 2 impacted wisdom teeth in the upper and lower jaws Pain VAS Value over 50 mm evaluated as 100mm VAS Subjects who voluntarily or legal guardian agreed with written consent Exclusion Criteria: Patients with severe heart disease, uncontrol hypertension, diabetes Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery) Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history Patients with severe respiratory depression

    12. IPD Sharing Statement

    Learn more about this trial

    Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery

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