A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
A Study of a Long-term Administration of JNS013 in Patients With Chronic Pain
2 other identifiers
interventional
219
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-pain
Started May 2008
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
June 20, 2013
CompletedJuly 2, 2014
June 1, 2014
1.4 years
August 14, 2008
March 25, 2013
June 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Visual Analogue Scale (VAS24) Score at 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.
Baseline and Week 4
Change From Baseline in VAS24 Score at 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.
Baseline and Week 52
Secondary Outcomes (5)
Number of Participants With Improvement From Baseline in VAS24 Score
Week 4 and 52
Pain Intensity Difference (PID) at Week 4
Week 4
Pain Relief (PAR) Score at Week 4
Week 4
Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4
Week 4
Change From Baseline in Short Form-36 (SF-36) Score
Baseline, Week 4 and 52
Study Arms (1)
Tramadol HCL plus Acetaminophen
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Chikushi, Japan
Unknown Facility
Chūō, Japan
Unknown Facility
Fukui, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Hiratsuka, Japan
Unknown Facility
Ichikawa, Japan
Unknown Facility
Kashiwa, Japan
Unknown Facility
Komatsu, Japan
Unknown Facility
Kukichūō, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Mihara, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Nerima City, Japan
Unknown Facility
Obihiro, Japan
Unknown Facility
Ogi, Japan
Unknown Facility
Ohta-Ku, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Tagawa, Japan
Unknown Facility
Taito-Ku, Japan
Unknown Facility
Takaoka, Japan
Unknown Facility
Tokyo, Japan
Unknown Facility
Urayasu, Japan
Unknown Facility
Yame, Japan
Unknown Facility
Yokohama, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K. 5-2, Nishi-kanda 3-chome, Cyiyoda-ku, Tokyo 101-0065 JAPAN
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 18, 2008
Study Start
May 1, 2008
Primary Completion
October 1, 2009
Study Completion
November 1, 2009
Last Updated
July 2, 2014
Results First Posted
June 20, 2013
Record last verified: 2014-06