Phase 3
Completed N=219
A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
Source: ClinicalTrials.gov NCT00736957 ↗Enrolled (actual)
219
Serious AEs
12.6%
Results posted
Jun 2013
Primary outcomePrimary: Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4 — 65.80; -22.28 millimeter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4 |
65.80; -22.28 | — |
| PRIMARY Change From Baseline in VAS24 Score at Week 52 |
65.80; -36.54 | — |
| SECONDARY Number of Participants With Improvement From Baseline in VAS24 Score |
76; 51; 110; 77 | — |
| SECONDARY Pain Intensity Difference (PID) at Week 4 |
0.1; 0.1 | — |
| SECONDARY Pain Relief (PAR) Score at Week 4 |
1.3; 1.3 | — |
| SECONDARY Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4 |
1.3; 1.4 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Score |
33.7; 2.9; 4.1; 35.0; 3.2; 6.0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00736957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.