CompletedNCT01920386Updated Oct 12, 2016

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

A Phase 3 interventional study of Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab. in Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery, sponsored by Daewon Pharmaceutical Co., Ltd.. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-10-12.

Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 240
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery

Browse trials for

Toothache 140

Keywords

Acute Toothache
Wontran
Wontran SR Tab.
Tramadol Hydrochloride/Acetaminophen

In context

Toothache

140 studies on the registry are indexed under Toothache; 24 are open to participants now.

This study's enrollment of 240 is above the median of 100 across 121 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 240 participants (actual)

Study arms

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.

Interventions

DrugTramadol hydrochloride/Acetaminophen Tab.
DrugTramadol hydrochloride/Acetaminophen SR Tab.

What researchers measure

Primary outcomes

SPID ; Sum of the pain intensity differences
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01920386
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Aug 12, 2013
Start date: Jun 2013
Primary completion: Sep 2013
Last update: Oct 12, 2016

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Daewon Pharmaceutical Co., Ltd.

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