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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

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: NCT01920386
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date October 12, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
SPID ; Sum of the pain intensity differences [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01920386 on ClinicalTrials.gov Archive Site
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 Acute Toothache Patients After Teeth Extraction Surgery
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 Acute Toothache Patients After Teeth Extraction Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
Intervention  ICMJE
  • Drug: Tramadol hydrochloride/Acetaminophen Tab.
  • Drug: Tramadol hydrochloride/Acetaminophen SR Tab.
Study Arms  ICMJE
  • Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.
    1tab PO within 5hours from teeth extraction
    Intervention: Drug: Tramadol hydrochloride/Acetaminophen Tab.
  • Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.
    1tab PO within 5hours from teeth extraction and then 1tab more after 6hours
    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
Actual Enrollment  ICMJE
 (submitted: October 11, 2016)
240
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT01920386
Other Study ID Numbers  ICMJE DW 0919 302 Version 1.0
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 October 2016

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