CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 328 enrolled
Drug / intervention
Tramadol Hydrochloride +3 moredrug
Likely dose
Tramadol Hydrochloride 75 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00737048
NCT00737048Phase 3Completed
CompareCT.gov

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

Janssen Pharmaceutical K.K.·interventional·Posted Aug 18, 2008·Updated Mar 31, 2016

In Brief

A Phase 3 clinical trial evaluating Tramadol Hydrochloride, Acetaminophen, and 2 other interventions for Pain and Postoperative Pain. Completed, enrolled 328 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative Pain
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2008
Enrollment StartMar 1, 2008
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.9 years ago

Interventions

Tramadol Hydrochloridedrug

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

Acetaminophendrug

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

Placebodrug

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

Tramadol plus Acetaminophendrug

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.