An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
CompletedPhase 3NCT00736853
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) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
Study details
- Official title
- A Phase 3 Study of JNS013 in Patients With Chronic Pain
- Conditions
- Interventions
- Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
- Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)
- Drug: Placebo (Double-Blind)
- Sponsor
- Janssen Pharmaceutical K.K.
- Start date
- 2008-06
- Primary completion
- 2009-01
- Sex
- All
- Age range
- from 20 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Japan
- Total sites listed
- 20
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Participants with sustention of chronic pain associated with OA or LBP for at least 3 months * Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study * Outpatients * Ambulatory participants without need for any supportive device or assistance during daily life Exclusion Criteria: * Participants with conditions for which opioids are contraindicated * Participants with conditions for which acetaminophen is 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/NCT00736853