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

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.

Timeline

Start

2008-03

Primary completion

2008-09

Completion

2008-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); Tramadol Hydrochloride Plus Acetaminophen and Placebo vs Tramadol Hydrochloride and Placebo; p <0.0001; Mean Difference (Final Values) -5.3; Fisher Least Significant Difference Method NCT00737048 ↗

registry analysis (superiority or other test); Tramadol Hydrochloride Plus Acetaminophen and Placebo vs Acetaminophen and Placebo; p <0.0001; Mean Difference (Final Values) -4.3; Fisher Least Significant Difference Method NCT00737048 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral

Indications

No indication recorded.