NCT00737048

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

A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm \[no pain\] to 100 mm \[worst possible pain\]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' safety will be monitored throughout the study.

Conditions

• Pain
• Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-08-18
• Last updated: 2016-03-31
• Results posted: 2013-08-01

Locations

11 sites across 1 country: Japan