A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
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|ClinicalTrials.gov Identifier: NCT00736957|
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : June 20, 2013
Last Update Posted : July 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of a Long-term Administration of JNS013 in Patients With Chronic Pain|
|Study Start Date :||May 2008|
|Primary Completion Date :||October 2009|
|Study Completion Date :||November 2009|
|Experimental: Tramadol HCL plus Acetaminophen||
Drug: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.
- Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4 [ Time Frame: Baseline and Week 4 ]Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
- Change From Baseline in VAS24 Score at Week 52 [ Time Frame: Baseline and Week 52 ]Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
- Number of Participants With Improvement From Baseline in VAS24 Score [ Time Frame: Week 4 and 52 ]Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
- Pain Intensity Difference (PID) at Week 4 [ Time Frame: Week 4 ]PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).
- Pain Relief (PAR) Score at Week 4 [ Time Frame: Week 4 ]Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression
- Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4 [ Time Frame: Week 4 ]PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).
- Change From Baseline in Short Form-36 (SF-36) Score [ Time Frame: Baseline, Week 4 and 52 ]SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736957
|Tokyo N/A, Japan|
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|