CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)drug
Likely dose
Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013) 37.5 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/NCT00736957
NCT00736957Phase 3Completed
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A Study of a Long-term Administration of JNS013 in Patients With Chronic Pain

Janssen Pharmaceutical K.K.·interventional·Posted Aug 18, 2008·Updated Jul 2, 2014

In Brief

A Phase 3 clinical trial evaluating Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013) for Chronic Pain. Completed, enrolled 219 participants across 25 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) with long term administration in participants with chronic pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2008
Enrollment StartMay 1, 2008
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.9 years ago

Interventions

Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)drug

Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.