A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
CompletedPhase 3NCT00736957
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- A Study of a Long-term Administration of JNS013 in Patients With Chronic Pain
- Conditions
- Interventions
- Drug: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
- Sponsor
- Janssen Pharmaceutical K.K.
- Start date
- 2008-05
- Primary completion
- 2009-10
- Sex
- All
- Age range
- from 20 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Japan
- Total sites listed
- 25
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00736957