Overview

A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain

Status:
Completed

Trial end date:
2009-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Janssen Pharmaceutical K.K.

Treatments:

Acetaminophen
Tramadol

Criteria

Inclusion Criteria:

- Participants whose pain cannot be controlled sufficiently with at least 14-day
continuous treatment with identical oral non steroid anti inflammatory drugs (NSAIDs)
at a usual maximum dose during 3 months prior to this study

- Ambulatory participants without need for any supportive device or assistance during
daily life

- Outpatients

- Participants who do not plan to change the therapeutic policy and content of the
medications for underlying disease during screening period to the end of Treatment
Period I

- Sustention of chronic pain due to Osteo Arthritis (OA), Low Back Pain (LBP),
Rheumatoid Arthritis (RA), Neck Shoulder Arm Syndrome (NSAS), Diabetic Neuropathy
(DN), Post herpetic Neuralgia (PHN) or other for at least 3 months

Exclusion Criteria:

- Participants with conditions for which opioids are contraindicated

- Participants with conditions for which APAP are contraindicated

- Participants with history of convulsion or the possibility of convulsive seizure

- Participants with concurrent, previous, or possible alcohol dependence, drug
dependence, or narcotic addiction

- Pregnant Participants or those who may be pregnant, lactating mothers, and
Participants who wish pregnancy during the study period.