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

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.

Condition or disease Intervention/treatment Phase
Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery Drug: Tramadol hydrochloride/Acetaminophen Tab. Drug: Tramadol hydrochloride/Acetaminophen SR Tab. Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.
1tab PO within 5hours from teeth extraction
Drug: Tramadol hydrochloride/Acetaminophen Tab.
Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.
1tab PO within 5hours from teeth extraction and then 1tab more after 6hours
Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

Primary Outcome Measures :
  1. SPID ; Sum of the pain intensity differences [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Daewon Pharmaceutical Co., Ltd. Identifier: NCT01920386    
Other Study ID Numbers: DW 0919 302 Version 1.0
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Keywords provided by Daewon Pharmaceutical Co., Ltd.:
Acute Toothache
Wontran SR Tab.
Tramadol Hydrochloride/Acetaminophen
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants