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A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain

NCT00737048 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2016-03-31

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.

Conditions

  • Pain
  • Postoperative Pain

Interventions

DRUG

Tramadol Hydrochloride

Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).

DRUG

Acetaminophen

Acetaminophen two oral capsules will be administered once as 650 mg.

DRUG

Placebo

Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.

DRUG

Tramadol plus Acetaminophen

Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737048 on ClinicalTrials.gov