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OpenTrials
Completed

NCT Number: NCT01920386

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

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.

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Key information

Conditions

Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol hydrochloride/Acetaminophen Tab.

Drug

Tramadol hydrochloride/Acetaminophen SR Tab.

Drug

Primary outcomes

  1. SPID ; Sum of the pain intensity differences

    Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
First posted
Aug 12, 2013
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.