NCT01920386

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

August 8, 2013

Last Update Submit

October 11, 2016

Conditions

Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery

Keywords

Acute ToothacheWontranWontran SR Tab.Tramadol Hydrochloride/Acetaminophen

Outcome Measures

Primary Outcomes (1)

  • SPID ; Sum of the pain intensity differences

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

Study Arms (2)

Tramadol hydrochloride/Acetaminophen Tab.

ACTIVE COMPARATOR

1tab PO within 5hours from teeth extraction

Drug: Tramadol hydrochloride/Acetaminophen Tab.

Tramadol hydrochloride/Acetaminophen SR Tab.

EXPERIMENTAL

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

Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

Interventions

Tramadol hydrochloride/Acetaminophen Tab.DRUG
Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.DRUG
Tramadol hydrochloride/Acetaminophen SR Tab.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

TramadolAcetaminophen

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsAcetanilidesAnilidesAmidesAniline Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 12, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Last Updated

October 12, 2016

Record last verified: 2016-10