Phase 3
N=319
An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00736853 ↗Enrolled (actual)
319
Serious AEs
0.2%
Results posted
Sep 2013
Primary outcome: Primary: Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period — 20; 43 number of participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tramadol Hydrochloride Plus Acetaminophen (Open-Label) (Drug); Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) (Drug); Placebo (Double-Blind) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period |
20; 43 | 0.0001 sig |
| SECONDARY Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period |
66.27; -28.17 | — |
| SECONDARY Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period |
30.33; 31.18; -0.67; 6.21 | — |
| SECONDARY Mean Pain Intensity (PI) Score During Open-Label Period |
1.7; 1.2; 1.1; 1.2; 1.0; 0.9 | — |
| SECONDARY Mean PI Score During Double-Blind Period |
1.2; 1.2; 1.0; 1.1; 1.0; 1.1 | — |
| SECONDARY Mean Pain Intensity Difference (PID) During the Open-Label Period |
0.4; 0.5; 0.2; 0.3 | — |
| SECONDARY Mean PID During the Double-Blind Period |
0.2; 0.1; 0.2; 0.1; 0.2; 0.1 | — |
| SECONDARY Mean Pain Relief (PAR) Score During the Open-Label Period |
1.2; 1.4; 1.7; 1.8 | — |
| SECONDARY Mean PAR Score During the Double-Blind Period |
1.7; 1.1; 1.8; 1.2; 1.9; 1.2 | — |
| SECONDARY Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period |
1.6; 1.9; 1.9; 2.2 | — |
| SECONDARY Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period |
1.9; 1.2; 2.0; 1.2; 2.1; 1.4 | — |
| SECONDARY Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period |
0.9; 0.5 | — |
| SECONDARY Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period |
0.4; 0.1; 0.5; 0.3; 0.4; 0.4 | — |
| SECONDARY Total Pain Relief (TOTPAR) Score During the Open-Label Period |
2.6; 3.5 | — |
| SECONDARY Total Pain Relief (TOTPAR) Score During the Double-Blind Period |
3.5; 2.3; 3.8; 2.6; 4.1; 3.3 | — |
| SECONDARY Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period |
3.5; 4.1 | — |
| SECONDARY Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period |
3.9; 2.4; 4.3; 3.0; 4.6; 3.7 | — |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period |
9.1; -2.6 | — |
| SECONDARY Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period |
6.5; 6.0; -0.5; 0.8 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period |
4.4; -1.9; 4.2; -1.5; 3.7; -1.5 | — |
| SECONDARY Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period |
2.6; 2.2; -0.3; 0.5; 2.7; 2.4 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period |
34.3; 3.9; 37.0; 4.3; 34.8; 5.4 | — |
| SECONDARY Change From Baseline in SF-36 at Day 28 of Double-Blind Period |
39.0; 39.7; 1.1; -1.6; 40.5; 41.8 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00736853). 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.